Ultimate Flora Extra Care Probiotic 50 Billion [Discontinued] by Renew Life

Colic. Oral Bifidobacterium lactis seems to be beneficial for colic. Details: Clinical research in infants with colic shows that taking B. lactis BB-12 (Chr. Hansen, Hoersholm or Bifidolactis Infant, Sofar SpA) drops providing 1 billion colony-forming units (CFUs) daily for 3 or 4 weeks modestly reduces the daily number of crying episodes by about 2.5 when compared with placebo. The proportion of infants with at least a 50% reduction in crying time from baseline was 61% to 80%, compared with 22% to 32% of those taking placebo. Use of B. lactis also resulted in increased sleep time, reduced crying duration, and improved physical and emotional functioning of the caregiver. Stool frequency was decreased in one study, but was not changed in the other (107583,107587).
Constipation. Oral Bifidobacterium lactis seems to be beneficial for constipation. Details: A meta-analysis of clinical research shows that taking B. lactis increases bowel movement frequency by about 1.5 stools weekly in adults with functional constipation. Specific strains used include LMG P-21384 as 5 billion colony-forming units (CFUs) daily, Bi-07 as 100 million CFUs daily, DN-173 010 as 12.5 billion CFUs daily, and GCL2505 as 10 billion CFUs daily for 2-4 weeks (95342). Another meta-analysis of clinical research in adults with chronic constipation shows that taking B. lactis modestly increases stool frequency when compared with taking placebo. However, there was no effect of taking B. lactis on treatment success, stool consistency, severity of straining or bloating, or gut transit time. Due to the small number of studies, the effect of B. lactis on other symptoms of constipation is unclear from this analysis (110874). A third meta-analysis shows that two specific strains of B. lactis, HN019 and DN-173 010, have medium to large effects on intestinal transit time in mainly healthy adults (110983). The effect of these strains on intestinal transit time in patients with constipation is unclear from this analysis. Clinical research in patients with low defecation frequency also shows that taking the specific B. lactis strain BB-12 (Chr. Hansen A/S) 1-10 billion CFUs daily for 4 weeks increases the odds of improved defecation frequency by about 1.3-fold when compared with placebo (92264). It is possible that any beneficial effect is limited to patients with more severe constipation. One clinical study in patients with functional constipation shows that taking the specific B. lactis strain HN019, 1 or 10 billion CFUs daily for 4 weeks, has no effect on bowel movements when compared with placebo. However, in a post-hoc analysis of patients with three or less weekly stools, this strain of B. lactis modestly increased bowel movements when compared with placebo (98737). Another clinical study in patients with mild chronic constipation shows that taking B. lactis NCC2818 15 billion CFUs daily for 4 weeks does not affect gut transit time, stool output, or symptoms when compared with placebo (102411). B. lactis has also been examined in combination with other ingredients. One small clinical trial using a specific combination product (ID-HWS1000) containing B. lactis IDCC 4301, Bifidobacterium breve IDCC 4401, Lacticaseibacillus casei IDCC 3451, Lactiplantibacillus plantarum IDCC 3501, Lacticaseibacillus rhamnosus IDCC 3201, Lactococcus lactis IDCC 2301, xylooligosaccharide, and dietary fiber as nondigestible maltodextrin, oat fiber, and psyllium husk fiber daily for 4 weeks modestly increases stool frequency and improves symptoms of functional constipation in adults when compared with placebo (107517). Another small clinical trial shows that taking yogurt 180 mL providing B. lactis HN019, L. acidophilus NCFM, and polydextrose (Litesse) daily for 2 weeks modestly improves clinical response and reduces transit time when compared with taking a control yogurt. However, there was no effect on the number of daily bowel movements (90275). Other studies have used B. lactis UABla-12, Bl-04, Bi-07, and/or HN019 in combination with Bifidobacterium bifidum UABb-10, Bifidobacterium longum UABl-14, Lactobacillus acidophilus DDS-1, and fructo-oligosaccharides (FOS) for 4 weeks (110970) or Lactobacillus acidophilus NCFM and Lacticaseibacillus paracasei Lpc-37 for 2 weeks (110979). However, there was a general lack of support for symptom improvement from these studies.
Irritable bowel syndrome (IBS). Oral Bifidobacterium lactis seems to be beneficial for reducing symptoms of IBS when used alone. Its benefits when used in combination with other probiotics are unclear. Details: Clinical research in adults with IBS shows that taking B. lactis UABla-12 10 billion colony-forming units (CFUs) daily for 6 weeks modestly reduces the severity of abdominal pain when compared with placebo. Also, 28% of patients responded to treatment by having more than a 30% reduction in pain severity, compared with only 16% of those taking placebo. There were also improvements in abdominal distention, duration of pain, and bowel habits (107581). Additional clinical research in children aged 4-16 years shows that taking B. lactis B19 10 billion CFUs daily for 4 weeks reduces bloating, feelings of abdominal fullness, and difficulty with defecation in 25% to 50% of patients with IBS (95350). Some research has also evaluated B. lactis in combination with other probiotics. Clinical research shows that taking a product (Duolac Care) containing B. lactis, Bifidobacterium breve, Lactobacillus acidophilus, Lactiplantibacillus plantarum, Lacticaseibacillus rhamnosus, and Streptococcus thermophilus twice daily for 4 weeks can relieve symptoms in 72% of patients with IBS (95353). Another clinical study in patients with diarrhea-predominant IBS shows that taking a specific multi-species probiotic (NordBiotic, MBM Biotix) containing B. lactis BL040, B. breve BB010, Bifidobacterium longum BL020, Bifidobacterium bifidum BF030, Lacticaseibacillus rhamnosus LR110, Lacticaseibacillus paracasei LPC100, L. acidophilus LA120, Lacticaseibacillus casei LC130, L. plantarum LP140, and Streptococcus thermophilus ST250 as 2.5 billion CFUs total twice daily for 8 weeks improves overall symptom severity, as well as pain severity, pain frequency, and quality of life when compared with placebo. Symptom severity was rated as mild by approximately 60% of those taking the probiotic mixture, compared with 30% of those taking placebo (107516). However, multiple studies show that taking capsules or drinking fermented milk containing a combination of B. lactis BB-12, L. paracasei, and L. acidophilus La510 as 26 billion CFUs total twice daily for 2-6 months does not improve gastrointestinal symptoms in patients with IBS (90236,94696,94697).
Respiratory tract infections. Most clinical research shows that taking Bifidobacterium lactis alone or in combination with other probiotics may reduce the risk of respiratory infections in otherwise healthy individuals. In patients who are not otherwise healthy, most clinical research shows that taking oral B. lactis has not demonstrated benefit. Details: Clinical research in infants aged 6 to 12 months shows that taking B. lactis HN019 one million colony-forming units (CFUs) per gram of follow-on formula daily for 12 weeks reduces the incidence of confirmed (9.4% vs. 0.0%) and parentally reported (25.0% vs. 9.4%) upper respiratory tract infections when compared to formula without added probiotics. Infants consumed an average of 141 grams of formula daily (110988). Another clinical trial in one month old infants shows that taking B. lactis BB-12 10 billion CFUs daily for an average of about 15 months reduces the proportion of children with respiratory tract infections until age 2 by 13% when compared with taking placebo. The frequency of recurrent respiratory tract infections was not different between groups (95381). In contrast, other clinical research in children attending day care shows that taking B. lactis BB-12 one billion CFUs daily for 3 months does not reduce the duration or incidence of respiratory tract infections (95382). Most research in children also shows that taking B. lactis in combination with other ingredients reduces the risk of respiratory infections. One clinical study shows that children ages 3-5 years who attend day-care centers have significantly fewer influenza-like respiratory symptoms when given milk containing a specific combination of 5 billion CFUs each of B. lactis and Lactobacillus acidophilus (HOWARU Protect, Danisco). Children taking this product seem to have a 45% lower risk of experiencing fever, cough, and rhinorrhea when compared with placebo. The duration of symptoms was also 2 days shorter. These patients were also less likely to use an antibiotic for their symptoms (16847). A clinical study in healthy children aged 3-10 years shows that taking 12.5 billion CFUs daily of a specific combination of B. lactis CUL34 (Lab4), Bifidobacterium bifidum CUL20, and L. acidophilus CUL21 and CUL60, plus vitamin C 50 mg daily reduces the risk of cough by 16% and sore throat by 20% and modestly reduces school absenteeism and antibiotic use when compared with placebo. However, nasal symptoms, fever, and wheezing were not reduced (106943). Another clinical study in children 3-12 years of age with a sick household member shows that taking a combination product (Up4-Junior, UAS Laboratories) containing B. lactis UABLA-12 4 billion CFUs and L. acidophilus DDS-1 1 billion CFUs with fructo-oligosaccharides 50 mg daily for 2 weeks modestly shortens the duration of respiratory infections, but does not reduce the risk of developing an infection, when compared with placebo (98439). In healthy children ages 3-6 years, taking a combination of B. lactis BB-12 and Enterococcus faecium L3 (iNatal Ped, Pharmextracta SpA) 2 billion CFUs each daily for 3 months reduces the incidence of upper respiratory tract infections by 84% compared with children not taking probiotics. The duration of infections was reduced by 50% (110991). The effect of B. lactis on respiratory tract infections has also been examined in adults. In healthy overweight adults or adults with obesity, taking 50 billion CFUs of a specific combination of B. lactis (Lab4P), B. bifidum, L. acidophilus, and Lactiplantibacillus plantarum for 24 weeks reduces the overall likelihood of having upper respiratory tract infection symptoms, such as sneezing, cough, and blocked nose, by approximately 40% when compared with placebo (103439). In college students, clinical research shows that taking B. lactis BB-12 and Lacticaseibacillus rhamnosus LGG one billion CFUs each daily for 12 weeks reduces the duration of upper respiratory tract infection by about 2 days when compared with placebo. Symptom severity was reduced by 34%. There was also a small reduction in the number of missed school days, but not work days (110993). Some research has investigated the effects of B. lactis on respiratory tract infection outcomes in patients who are not otherwise healthy. One clinical trial in children hospitalized with an acute respiratory tract infection shows that taking B. lactis Probio-M8 20 billion CFUs daily from admission until 4 weeks after discharge modestly reduces the duration of nasal, throat, and general aching symptoms when compared with taking placebo. Taking B. lactis also modestly reduced the proportion of patients requiring hospitalization of at least 7 days (110984). Despite these findings, another clinical trial in children and adolescents who are hospitalized shows that taking B. lactis 100 million CFUs daily during a hospital stay does not reduce the incidence or duration of respiratory infections, including common cold, rhinitis, sinusitis, and others, when compared with placebo (92265). Also, in older adults in long-term care, taking a combination of B. lactis BB-12 and Lacticaseibacillus rhamnosus 13-16 billion CFUs daily does not reduce the incidence of upper or lower respiratory infections when compared with placebo over a 12-month period, and increases the use of antibiotics for lower respiratory tract infections by 2.2 days (103425).

Dental caries. Oral Bifidobacterium lactis does not seem to be beneficial for preventing dental caries in young children. Details: Clinical research in infants shows that giving B. lactis BB-12 DSM 15954 (Chr. Hansen A/S) 5 billion colony-forming units (CFUs) daily, starting at age 1-2 months and continuing for an average of 15 months, through a sustained-release pacifier or tablet does not reduce the incidence of dental caries at age 4 when compared with placebo (107588).

Allergic rhinitis (hay fever). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children aged 6-17 years with allergic rhinitis shows that taking a specific combination product (Inatal ped Pharmaextracta) containing B. lactis BB-12 DSM 15954 and Enterococcus faecium L3 LMG P-27496 2 billion colony-forming units (CFUs) each with oligofructose daily for 3 months prior to a high allergen exposure period the period modestly reduces symptoms of allergic rhinitis and the need for corticosteroids and/or oral antihistamines when compared with baseline (107582). However, other clinical research shows that drinking 250 mL of fermented milk containing B. lactis BB-12 50 billion CFUs, Lacticaseibacillus rhamnosus GG 50 billion CFUs, and Lactobacillus acidophilus La-5 5 billion CFUs from 36 weeks' gestation until 3 months postpartum does not reduce the incidence of allergic rhinitis in the child at 6 years of age when compared with placebo milk (96893).
Antibiotic-associated diarrhea. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of 6 clinical trials in hospitalized or outpatient adults shows that taking B. lactis in combination with up to 8 other probiotic strains reduces the risk of antibiotic-associated diarrhea by 30% when compared with taking placebo (107635). However, individual clinical trials have mixed results. Some specific combination products containing B. bifidum have shown benefit for antibiotic-associated diarrhea (AAD). One such product is Ecologic AAD, which contains B. lactis NIZO 3680, Bifidobacterium bifidum NIZO 3804, Enterococcus faecium NIZO 3886, L. acidophilus NIZO 3678 and NIZO 3887, Lacticaseibacillus paracasei NIZO 3672, Lactiplantibacillus plantarum NIZO 3684, Lacticaseibacillus rhamnosus NIZO 3689, and Ligilactobacillus salivarius NIZO 3675. Another evaluated product contains B. lactis BB-12 5.9 billion CFUs daily, L. rhamnosus GG 5.2 billion CFUs, and L. acidophilus La-5 8.3 billion CFUs daily. However, other combinations do not appear to be beneficial. These include B. lactis BB-12 and L. acidophilus LA-5; B. lactis BB-12 and L. rhamnosus; B. lactis, B. bifidum, and L. acidophilus; and B. lactis W51, B. bifidum W23, L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L. rhamnosus W71, and L. salivarius W24 (90239,92255,94692,95348,95405,103425,110969). It is too soon to know which combinations might be most beneficial, if any, for preventing AAD.
Atopic dermatitis (eczema). It is unclear if oral Bifidobacterium lactis is beneficial for the prevention or treatment of atopic dermatitis. Details: Some research has evaluated B. lactis for TREATING atopic dermatitis. One very small clinical study shows that giving infants a formula containing B. lactis BB-12 (Chr. Hansen A/S) 30-80 billion colony-forming units (CFUs) daily helps reduce the severity of eczema and the markers for allergic responses, including soluble CD4 in serum and eosinophilic protein X in urine when compared with baseline (3458). However, preliminary clinical research shows that giving B. lactis CNCM I-3446 10 billion CFUs to infants as an adjunct to standard topical treatment daily for 3 months does not reduce eczema severity when compared with placebo (90256). B. lactis has also been investigated in combination with other ingredients. In children, taking B. lactis as part of a multi-ingredient formulation for 8 or 12 weeks modestly reduces symptom severity and the need for topical corticosteroids when compared with placebo (107531,110995). In these studies, 1 billion CFUs of a 1:1:1 combination of B. lactis CECT 8145, Lacticaseibacillus casei CECT 9104, and Bifidobacterium longum CECT 7347 daily was used in children ages 4-17 years for 12 weeks (107531) or B. lactis UABLA-12 was taken in combination with Lactobacillus acidophilus DDS-1 for a total of 10 billion CFUs daily along with fructo-oligosaccharide 100 mg (DDS Junior) daily for 8 weeks by children ages 1-3 years (110995). B. lactis-containing probiotics have also been investigated for PREVENTING atopic dermatitis. A meta-analysis of small- to medium-sized studies shows that providing mixed strains of lactobacilli and bifidobacteria to infants during pregnancy and/or in early infancy prevents atopic dermatitis in the child by approximately 40% over the next 0.5-2 years (107503). Although this analysis was not limited to studies examining the effects of B. lactis, seven of the nine studies used B. lactis as part of a combination product. Individual studies included in the analysis have shown that taking a combination of B. lactis, Bifidobacterium bifidum, Ligilactobacillus salivarius, and Lacticaseibacillus paracasei during pregnancy from approximately 35 weeks' gestation until birth, and then giving this combination to the infant after birth until 6 months of age, does not reduce the incidence of eczema at age 2 years, although it does appear to reduce the risk of atopic sensitization by 57% (90234). A secondary analysis of a clinical study included in this analysis in infants aged 8-14 months found that taking a daily mixture of B. lactis and Lacticaseibacillus rhamnosus 1 billion CFUs each daily for 6 months is associated with a lower incidence of eczema when compared with placebo (102286). Also, some clinical research shows that supplementation with 250 mL of fermented milk containing B. lactis BB-12, Lacticaseibacillus rhamnosus GG, and Lactobacillus acidophilus La-5 starting at 36 weeks' gestation and continuing until 3 months postpartum, without supplementation in the infant, reduces the overall occurrence of atopic dermatitis in the child at 2 years of age. At 6 years of age, the effect appears to be inconclusive (96893).
Bipolar disorder. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with bipolar disorder who were recently hospitalized for a manic episode shows that taking a combination probiotic containing B. lactis BB-12 and Lacticaseibacillus rhamnosus GG 100 million colony-forming units daily for 24 weeks reduces the risk of rehospitalization when compared with placebo. The hazard ratio for the first rehospitalization due to worsening of psychiatric symptoms was 0.37 for the combination probiotic group when compared with placebo. Among patients who were re-hospitalized, taking the combination probiotic reduced the mean duration of rehospitalization by 5.4 days when compared with placebo (96896).
Cancer. Although there has been interest in using oral Bifidobacterium lactis for cancer prevention or treatment, there is insufficient reliable information about the clinical effects of B. lactis for this condition.
Canker sores. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small study shows that taking a combination of B. lactis, Lacticaseibacillus paracasei, Lacticaseibacillus rhamnosus, and Lactobacillus acidophilus reduces pain, but does not affect the number of lesions or healing time, when compared with placebo. Also, another small study shows that using lozenges providing inulin 0.13 gram along with B. lactis and L. acidophilus 1.5 billion colony-forming units each reduces pain, but does not affect ulcer size or healing, when compared with Oracure gel (105146).
Child development. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: An 11-year follow-up study evaluating B. lactis and Lacticaseibacillus rhamnosus taken daily during pregnancy from 35 weeks' gestation until birth, or six months after birth if breastfeeding, and then giving the same supplement to the infant until 2 years of age, does not affect neurocognitive outcomes such as attention, intelligence, executive function, depression, and anxiety when compared with those taking placebo (102287).
Clostridioides difficile infection. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A large clinical study in inpatients aged 65 years or older shows that taking a combination of B. lactis, Bifidobacterium bifidium, and Lactobacillus acidophilus 60 billion colony-forming units daily for 21 days does not reduce the incidence of C. difficile diarrhea when compared with placebo (92255). Other combinations also do not appear to be beneficial, including a combination of B. lactis Bi-04, B. lactis Bi-07, Lactobacillus acidophilus, and Lacticaseibacillus paracasei, as well as a combination of B. lactis Bb-12, Lacticaseibacillus rhamnosus GG, and L. acidophilus La-5 (95364).
Critical illness (trauma). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in multi-trauma patients requiring ventilation shows that taking a combination probiotic containing B. lactis twice daily for 15 days modestly reduces the risk of sepsis, as well as the length of stay in the ICU and hospital, when compared with placebo. The product contained B. lactis BB12 1.75 billion colony-forming units (CFUs) in combination with Lactobacillus acidophilus LA-5 1.75 billion CFUs, Lactiplantibacillus plantarum 500 million CFUs, and Saccharomyces boulardii 1.5 billion CFUs. Half of the dose was given onto the oropharynx and half via a nasogastric tube (107524).
Dental plaque. It is unclear if Bifidobacterium lactis is beneficial for preventing dental plaque. Details: Preliminary clinical research shows that consuming a yogurt supplemented with B. lactis DN-173010 100 million colony-forming units daily between breakfast and lunch for 4 weeks does not prevent gingivitis or plaque when compared with a placebo yogurt. However, following a non-brushing period of 5 days, both gingivitis and plaque were modestly reduced in individuals consuming the B. lactis-containing yogurt (98502). Clinical research in adolescent boys aged 13-15 years with mild to moderate gingival inflammation shows that taking two lozenges containing B. lactis BB-12 (Chr. Hansen A/S) and Lacticaseibacillus rhamnosus GG (Probiotical SpA) twice daily for 4 weeks does not reduce plaque when compared with placebo. However, there was a benefit on levels of some salivary and plaque pathogenic bacteria. Each lozenge provided B. lactis BB-12 470 million colony-forming units (CFUs) and L. rhamnosus 440 million CFUs (107574). Conversely, a small clinical trial in healthy adults shows that taking four lozenges daily providing a total daily dose of 2 billion CFUs each of B. lactis BB-12 DSM 15954 (Chr. Hansen A/S) and L. rhamnosus GG ATCC 53103 (Probiotical SpA) for 4 weeks modestly reduces plaque when compared with placebo (107572).
Diabetes. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of four clinical trials shows that taking probiotics during pregnancy is unlikely to prevent gestational diabetes and increases the risk of pre-eclampsia by 85% when compared with placebo. Although the specific effects of B. lactis are unclear from this analysis, three of the included studies used B. lactis in combination with Lacticaseibacillus rhamnosus (105185). Other clinical research that has found no benefit has used B. lactis BB-12 and L. rhamnosus GG at least 1 billion CFUs daily from 16-20 weeks' gestation until 28 weeks' gestation, or B. lactis 420 DSM 22089 (Dupont Nutrition & Health) and L. rhamnosus HN001 ATCC SD5675 as 10 billion CFUs each daily throughout pregnancy, with or without fish oil (102284,105144). Conversely, one small clinical study in adults with gestational diabetes shows that taking a combination of B. lactis BB-12, Streptococcus thermophilus STY-31, Lactobacillus acidophilus LA-5, and Lactobacillus delbrueckii subsp. bulgaricus LBY-27 for 8 weeks, starting at 24-28 weeks' gestation, modestly reduces fasting blood glucose and improves insulin sensitively when compared with placebo (96892). In children aged 8-17 years with type I diabetes, taking B. lactis Bb12 DSM 15954 and L. rhamnosus GG ATCC 53103 1 billion CFUs daily for 6 months does not reduce insulin requirements or levels of glycated hemoglobin over 12 months when compared with placebo. In addition, C-peptide levels and the maintenance of residual pancreatic beta-cell function were not affected (107518). A small clinical trial in adults with type 2 diabetes shows that taking fermented goat milk 120 grams containing one billion colony-forming units each of B. lactis BB-12 and Lactobacillus acidophilus La-5 daily for 6 weeks modestly reduces levels of glycated hemoglobin and low-density lipoprotein (LDL) cholesterol, but not fasting blood glucose or insulin resistance, when compared with conventional fermented milk containing Streptococcus thermophilus TA-40 (110973).
Diarrhea. It is unclear if oral Bifidobacterium lactis is beneficial for the treatment or prevention of diarrhea. Details: The European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388). However, B. lactis is not a specific focus of the guidelines and most evidence is low quality. Clinical research shows that B. lactis reduces the duration of acute diarrhea in children by about one day (107636). In older adults in long-term care, clinical research shows that taking a combination of B. lactis BB-12 and Lacticaseibacillus rhamnosus 13-16 billion colony-forming units daily does not reduce the incidence or duration of diarrhea over a 12-month period when compared with placebo (103425).
Familial hypercholesterolemia. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children 6-18 years of age with high cholesterol shows that taking a probiotic containing B. lactis MB 2409, Bifidobacterium bifidum MB 109, and Bifidobacterium longum BL04 daily for 12 weeks decreases total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglyceride levels by 2% to 3% and increases HDL cholesterol levels by about 2% when compared with placebo. However, these changes might not be considered clinically significant (98736).
Generalized anxiety disorder (GAD). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in patients newly diagnosed with GAD shows that taking sertraline 25 mg plus probiotics daily for 8 weeks may modestly reduce some symptoms of anxiety when compared with sertraline alone. However, the reduction in anxiety score was small and change was not consistent between rating scales. Also, the quality of life was not improved. The probiotics provided a total of 18 billion colony-forming units of B. lactis, Bifidobacterium longum, Bifidobacterium bifidum, and Lactobacillus acidophilus (110977).
Gingivitis. It is unclear if oral Bifidobacterium lactis is beneficial for gingivitis. Details: Preliminary clinical research shows that consuming a yogurt supplemented with B. lactis DN-173010 100 million colony-forming units (CFUs) daily between breakfast and lunch for 4 weeks does not prevent gingivitis or plaque when compared with a placebo yogurt. However, following a non-brushing period of 5 days, both gingivitis and plaque were modestly reduced in individuals consuming the B. lactis-containing yogurt (98502). Another clinical trial following cleaning in patients with gingivitis shows that taking lozenges containing B. lactis HN019 (HOWARU Bifdo LYO 40 DCU-S, Danisco) one billion CFUs twice daily for 8 weeks increases the proportion of patients without generalized gingivitis by almost 50%, and modestly reduces bleeding with probing and gingivitis severity, compared with placebo lozenges. There was no effect on plaque (110992). B. lactis has also been investigated in combination with other ingredients. Clinical research in adolescent boys aged 13-15 years with mild to moderate gingival inflammation shows that taking two lozenges containing B. lactis BB-12 (Chr. Hansen A/S) and Lacticaseibacillus rhamnosus GG (Probiotical SpA) twice daily for 4 weeks modestly reduces gingivitis when compared with placebo. Each lozenge provided B. lactis BB-12 480 million colony-forming units (CFUs) and L. rhamnosus 440 million CFUs (107574). A small clinical trial in healthy adults shows that taking four lozenges daily providing a total daily dose of 2 billion CFUs each of B. lactis BB-12 DSM 15954 (Chr. Hansen A/S) and L. rhamnosus GG ATCC 53103 (Probiotical SpA) for 4 weeks modestly reduces plaque and gingivitis when compared with placebo (107572).
Helicobacter pylori. It is unclear if oral Bifidobacterium lactis is beneficial for H. pylori; some research suggests that B. lactis may minimize the adverse effects of H. pylori eradication therapy, but not all research agrees. Details: Preliminary clinical research shows that adding B. lactis B94 7 billion colony-forming units (CFUs) daily to sequential H. pylori eradication therapy for 2 weeks results in an eradication rate of 87%, compared with 71% of those taking placebo or using no control along with sequential eradication therapy. Use of B. lactis also reduced treatment non-compliance due to diarrhea during the first week and reduced symptoms such as loss of appetite, nausea, and abdominal pain. In order to have one beneficial outcome, 6.2 patients would need to take B. lactis. There was no overall effect on non-compliance related to diarrhea or to skin rash (107589). Another clinical study shows that taking a specific combination of B. lactis and a lactobacilli species (Ferzym, Specchiasol) 5 billion CFUs daily for one week during standard triple therapy and one week thereafter reduces some treatment-related adverse effects such as taste disturbances and diarrhea, although it does not seem to improve compliance (12763). However, there was no difference in eradication rates or symptom relief in children aged 6-16 years taking B. lactis B94 5 billion CFUs daily plus inulin 900 mg for 14 days along with standard triple therapy (107590). Discrepancies may be related to the population studied or to the B. lactis strain, the other ingredients, or the type of H. pylori treatment used in the available research.
Hypercholesterolemia. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of nine small to moderate-sized clinical studies shows that taking a combination of B. lactis and Lactobacillus acidophilus reduces levels of total cholesterol when compared with placebo (107591). Populations in the included clinical trials enrolled patients with hypercholesterolemia, type 2 diabetes, nonalcoholic fatty liver disease (NAFLD), metabolic syndrome, and others. The benefits of B. lactis in patients with hypercholesterolemia are unclear.
Inflammatory bowel disease (IBD). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial shows that taking 10 billion colony-forming units each of B. lactis BB-12 and Lactobacillus acidophilus LA-5 twice daily for 12 weeks does not increase the proportion of patients with a reduction in weekly bowel frequency of at least 50% when compared with placebo. Also, there was no effect of this combination on stool consistency or abdominal symptoms. However, there were some modest benefits when compared with baseline (110999). This study was small and may have been underpowered to detect differences.
Malnourishment-related diarrhea. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children aged 6 months to 4 years of age hospitalized with severe acute malnutrition shows that taking B. lactis BB-12 and Lacticaseibacillus rhamnosus LGG 5 billion colony-forming units each daily during hospitalization and for 8-12 weeks as an outpatient does not affect diarrhea incidence or severity or the number of days with diarrhea during hospitalization. However, the number of days with diarrhea as an outpatient was reduced by 2.2 days (110996).
Malnutrition. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children aged 6 months to 4 years of age hospitalized with severe acute malnutrition shows that taking B. lactis BB-12 and Lacticaseibacillus rhamnosus LGG 5 billion colony-forming units each daily during hospitalization and for 8-12 weeks as an outpatient does not affect pneumonia incidence, duration, or severity, weight gain, duration of hospitalization, or other outcomes (110996).
Metabolic syndrome. It is unclear if oral Bifidobacterium lactis is beneficial for metabolic syndrome. Details: In patients with metabolic syndrome, preliminary clinical research shows that taking fermented milk 80 mL providing B. lactis HN019 27.2 billion colony-forming units daily for 45 days reduces body mass index by approximately 4% and low-density lipoprotein (LDL) cholesterol by approximately 14% when compared with no treatment. There was no effect on waist circumference, glucose control, or other blood lipids (105154).
Necrotizing enterocolitis (NEC). It is unclear if oral Bifidobacterium lactis is beneficial for NEC prevention. Details: Meta-analyses of clinical research generally show that giving various bifidobacteria species alone does NOT reduce the risk of NEC or all-cause mortality. However, only a few of the studies included in these analyses have used B. lactis (95344,95351,103437,105164). A systematic review of four studies using B. lactis shows that although NEC incidence is reduced by 89% in one study, a significant reduction was not identified in the other studies when compared with placebo (107592). More research is needed to determine the role of B. lactis in the prevention of NEC.
Neonatal jaundice. It is unclear if oral Bifidobacterium lactis is beneficial for neonatal jaundice. Details: Clinical research in newborns with jaundice shows that taking B. lactis CP-9 5 billion colony-forming units twice daily during conventional phototherapy treatment reduces the duration of phototherapy by about 13 hours and modestly improves the decline in serum bilirubin when compared with taking placebo. A sub-analysis shows that this benefit is limited to full-term, and not preterm, newborns (110987).
Nonalcoholic fatty liver disease (NAFLD). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In children with NAFLD, clinical research shows that taking a specific combination (Prokid, Gostaresh Milad Pouya Company) containing B. lactis DSMZ 32269 6 billion colony-forming units (CFUs), Lactobacillus acidophilus ATCC B3208 3 billion CFUs, Lacticaseibacillus rhamnosus DSMZ 21690 2 billion CFUs, and Bifidobacterium bifidum ATCC SD6576 2 billion CFUs daily for 12 weeks normalizes liver sonography findings in 53% of children, compared with 17% of those taking placebo. In addition, levels of alanine aminotransferase and aspartate aminotransferase are reduced by 30% and 25%, respectively. There was no effect on body mass index or blood lipids when compared with placebo (105156). However, other research in adults with NAFLD shows that taking probiotic yogurt 100 grams fortified with vitamin D 1000 IU plus B. lactis Bb-12 and L. acidophilus 40 million CFUs daily for 3 months does not improve fasting blood glucose levels, insulin levels, blood pressure, or anthropometric indices when compared with unfortified yogurt (105174).
Obesity. It is unclear if oral Bifidobacterium lactis is beneficial for weight loss. Details: Clinical research in overweight and obese adults shows that taking B. lactis 420 10 billion colony-forming units (CFUs) daily for 6 months does not reduce body fat or body weight when compared with placebo (95356). However, in individuals with abdominal obesity, clinical research shows that taking B. lactis CECT 8145 (Ba8145) 10 billion CFUs for 3 months modestly decreases body mass index (BMI) when compared with placebo. Also, taking heat-killed B. lactis CECT 8145 (Ba8145) 10 billion CFUs modestly decreases waist circumference when compared with placebo. Sub-group analyses show that these benefits occur only in females, and there was no effect of these products on the visceral or subcutaneous fat areas when compared with placebo (105551). Another clinical trial shows that taking 10 billion colony-forming units each of B. lactis 420 and Lacticaseibacillus rhamnosus HN001 daily, alone and with fish oil providing eicosapentaenoic acid 0.22 grams and docosahexaenoic acid 1.9 grams (Croda Europe Ltd.), during pregnancy and for 6 months postpartum, reduces the odds of overweight at 24 months by approximately 64% or 78%, respectively, when compared with taking placebo (110336). When taken in combination with Lactobacillus acidophilus LA02, B. lactis BS01 2 billion CFUs daily for 6 weeks does not reduce body weight or body fat when compared with placebo in young, healthy individuals, only some of whom were overweight (103438). In contrast to these findings, clinical research shows that taking 50 billion CFUs of a specific combination of B. lactis, Bifidobacterium bifidum, L. acidophilus, and Lactiplantibacillus plantarum (Lab4P) for 24 weeks reduces body weight by an additional 1.3 kg more than placebo (103439). Heat-killed B. lactis has also been investigated in combination with other ingredientd. Clinical research shows that taking enriched seafood sticks 50 grams daily providing heat-inactivated B. lactis CECT 8145 5 billion colony-forming units, inulin 1.7 grams, and eicosapentaenoic acid plus docosahexaenoic acid 370 mg daily for 12 weeks does not reduce body weight, body fat, blood pressure, or most lipid or glycemic indices, when compared to taking conventional seafood sticks. There was a modest decrease in insulin levels in males (110997).
Oropharyngeal candidiasis. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In older adults in long-term care, clinical research shows that taking a combination of B. lactis BB-12 and Lacticaseibacillus rhamnosus 13-16 billion colony-forming units daily does not reduce the incidence of oropharyngeal candidiasis when compared with placebo over a 12-month period (103425).
Otitis media. It is unclear if oral Bifidobacterium lactis is beneficial for preventing otitis media. Details: Clinical research in one month old infants shows that taking B. lactis BB-12 10 billion colony-forming units daily for an average of about 15 months does not reduce the proportion of children with otitis media by two years of age when compared with taking placebo (95381).
Periodontitis. It is unclear if oral Bifidobacterium lactis is beneficial for periodontitis. Details: In patients with periodontitis, a small clinical trial shows that taking B. lactis HN019 lozenges providing 1 billion colony-forming units twice daily (HOWARU1 Bifido LYO 40 DCU-S, DuPont Danisco Sweeteners Oy) for 30 days after scaling and root planing modestly improves some measures of periodontitis 60 days after treatment completion, including pocket depth and clinical attachment, when compared with using placebo lozenges. In addition, although the risk for disease progression was not improved when compared with placebo, there was a reduction in the need for additional therapy in at least three sites (105157,105158,107622).
Postoperative bowel function. It is unclear if oral Bifidobacterium lactis is beneficial for improving postoperative bowel function. Details: Clinical research in patients undergoing colorectal polyp resection shows that taking B. lactis MH-02 2 billion colony-forming units daily for 7 days postoperatively does not reduce total postoperative gastrointestinal symptom severity when compared with taking placebo. However, the time to recovery of bowel function was reduced by about 0.7 days and there were modest improvements in defecation difficulty (110985).
Postpartum depression. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that taking a combination of B. lactis 420 DSM 22,089 and Lacticaseibacillus rhamnosus HN001 ATCC SD5675 (Dupont Nutrition & Health) 10 billion CFUs daily, alone or with fish oil providing eicosapentaenoic acid (EPA) 0.44 grams and docosahexaenoic acid (DHA) 3.8 grams daily, does not reduce symptoms of postpartum depression or anxiety when compared with placebo. Supplements were started in the second trimester of pregnancy and continued until 6 months after delivery (107496).
Prader-Willi syndrome (PWS). It is unclear if oral Bifidobacterium lactis is beneficial for PWS. Details: A small clinical trial in children with PWS shows that taking B. lactis BPL1 CECT8145 (Archer Daniels Midland Co-Biópolis) 10 billion colony-forming units (CFUs) daily for 12 weeks does not improve fat mass, abdominal adiposity, lipid profile, blood pressure, or glucose control when compared with placebo. However, there was a small improvement in insulin levels and measures of insulin resistance. Also, abdominal adiposity was modestly improved in a sub-group of patients over age 4.5 years, the age at which excessive weight gain typically starts in this population (105149). Other clinical research in children with PWS shows that taking B. lactis BL-11 (Beijing Huayuan Academy of Biotechnology) 30 billion CFUs twice daily for 12 weeks does not affect weight or psychological outcomes, including behavior, communication, and motor skills, when compared with placebo. However, height and overall clinical impression were modestly improved (107585).
Pregnancy-induced nausea and vomiting. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial shows that taking probiotics during pregnancy reduces the severity and duration of nausea and vomiting by 16% to 54%. There was also a small benefit on stool hardness. A specific probiotic (Probiotics 10, Nature's Bounty) was taken as 2 capsules daily for two back-to-back cycles comprised of six days with probiotics and two days without. Each capsule contained a total of 10 billion colony-forming units (CFUs) of B. lactis Bl-04, Lactiplantibacillus plantarum 299v and DSM 15312, Lactobacillus delbrueckii subsp. bulgaricus Lb-87, Lacticaseibacillus paracasei DSM 13434 and Lpc-37, Ligilactobacillus salivarius Ls-33, Levilactobacillus brevis Lbr-35, Lactobacillus acidophilus La-14, and Lacticaseibacillus casei Lc-11, along with inulin 200 mg (107199).
Prematurity. It is unclear if oral Bifidobacterium lactis is beneficial for preventing infections in premature infants. Details: A small clinical trial in very low birth weight premature infants shows that taking B. lactis BB-12 two billion colony-forming units per kg six times daily from birth for 6 weeks does not reduce the incidence of nosocomial infections when compared with taking placebo (110994). This study may have been too small to detect differences.
Psoriasis. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with psoriasis shows that taking a mixture of probiotics for 8 weeks modestly improves overall disease symptoms and feelings of depression when compared with placebo. The percentage of patients achieving at least a 50% or 75% reduction in overall symptom score was 40% and 24%, respectively, compared with 16% and 8% of those taking placebo. The probiotic was taken twice daily and provided a total daily dose of 2.6 billion colony-forming units (CFUs) of B. lactis, Bifidobacterium bifidum, Bifidobacterium longum, and Lactobacillus acidophilus (107498).
Radiation-induced diarrhea. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with cervical cancer receiving radiotherapy with or without chemotherapy shows that taking a specific product (Biogurt, Fame Pharmaceuticals) containing B. lactis BB-12 and Lactobacillus acidophilus LA-5 1.75 billion lyophilized live colony-forming units in a capsule three times daily throughout radiation treatment reduces the risk of diarrhea by 28% when compared with placebo. Taking probiotics also reduced the use of loperamide when compared with placebo (102285).
Rheumatoid arthritis (RA). Although there has been interest in using oral Bifidobacterium lactis for RA, there is insufficient reliable information about the clinical effects of B. lactis for this condition.
Rotaviral diarrhea. It is unclear if oral B. lactis is beneficial for rotaviral diarrhea. Details: Small clinical studies show that giving B. lactis BB-12 alone or along with Streptococcus thermophilus may help reduce the incidence of diarrhea and rotavirus shedding in infants and children up to 36 months old (3169).
Ulcerative colitis. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial shows that taking a specific product (Probio-Tec AB-25) containing B. lactis BB-12 and Lactobacillus acidophilus La-5 is not beneficial for preventing relapse in patients with ulcerative colitis when compared with placebo (95338).
Urinary tract infections (UTIs). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients in adults and children; its effect when used alone is unclear. Details: In children aged 4 months to 5 years with a previous UTI, clinical research shows that taking a specific combination (Complete Probiotic Platinum) of B. lactis 750 million colony-forming units (CFUs), Bifidobacterium bifidum 200 million CFUs, Lactobacillus acidophilus 750 million CFUs, and Lacticaseibacillus rhamnosus 50 million CFUs per kg twice daily for 18 months increases the median time to the first incidence of recurrence by approximately 3 months and increases the percentage of children without a UTI during the study period from 83% to 97% (103436). However, in older adults in long-term care, taking a combination of B. lactis BB-12 and L. rhamnosus 13-16 billion CFUs daily does not reduce the incidence of UTI when compared with placebo over a 12-month period (103425).
Ventilator-associated pneumonia (VAP). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that taking B. lactis BB12 1.75 billion colony-forming units (CFUs), Lactobacillus acidophilus LA-5 1.75 billion CFUs, Lactiplantibacillus plantarum 500 million CFUs, and Saccharomyces boulardii 1.5 billion CFUs twice daily for 15 days reduces the risk of VAP to 12%, compared with 28% of patients taking placebo. Half of the dose was given onto the oropharynx and half via a nasogastric tube (107524). More evidence is needed to rate Bifidobacterium lactis for these uses.

Age-related cognitive decline. Oral Bifidobacterium breve does not seem to improve cognition in older adults. Details: A small clinical study in patients over 65 years of age shows that taking a sachet (Morinaga Milk Industry Co., Ltd) containing lyophilized powder of B. breve M-16V and B-3 and Bifidobacterium longum BB536 and M-63 as 12.5 billion colony-forming units each with water daily for 12 weeks does not improve cognition as measured on the Montreal Cognitive Assessment (MoCA) when compared with placebo (102412). While the results of this study may have been limited by the small population size, a larger clinical study in adults ages 50-80 years with subjective memory complaints also shows that using the same product for the same duration does not improve cognition when compared with placebo (102414).
Sepsis. Oral Bifidobacterium breve does not seem to prevent sepsis in preterm infants. Details: One large, well-designed clinical study in preterm infants shows that taking B. breve BBG-001 up to about 90 billion colony-forming units (CFUs) daily in formula does not reduce the risk of sepsis when compared with placebo (92256). An additional smaller clinical trial also shows that taking B. breve M-16V 3 billion CFUs daily does not reduce the risk of sepsis (111008).

Allergic rhinitis (hay fever). Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in children ages 4-17 years with allergic rhinitis and intermittent asthma related to Parietaria officinalis pollen shows that taking a combination of B. breve M-16 V one billion colony-forming units (CFUs), Bifidobacterium longum subsp. infantis M-63 one billion CFUs, and B. longum subsp. longum BB536 3 billion CFUs daily for 8 weeks modestly improves symptoms of rhinitis and quality of life when compared to taking placebo. There was no difference in the use of rescue medication (111001).
Antibiotic-associated diarrhea. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in hospitalized patients with antibiotic-associated diarrhea shows that taking a combination of B. breve 50 million colony-forming units (CFUs) and Lacticaseibacillus casei 20 million CFUs three times daily does not reduce the average duration of diarrhea, the frequency of healing, or relapse rates, when compared with taking placebo (111006).
Asthma. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A large clinical trial in children ages 3-14 years with asthma shows that taking a combination of B. breve B632 (DSM 24706) and Ligilactobacillus salivarius LS01 (DSM 22775) one billion colony-forming units (CFUs) each twice daily for 8 weeks and then once daily for 8 weeks modestly reduces the number of asthma exacerbations. The odds of having one or two asthma exacerbation was more than three fold in children taking placebo when compared with children taking probiotics. There was no effect on the duration of exacerbation or use of corticosteroids (111004).
Atopic dermatitis (eczema). Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a total of 10 billion colony-forming units (CFUs) daily of a combination of B. breve M-16V and Bifidobacterium longum subsp. longum BB536 from about 4 weeks before the expected due date until delivery and then giving 5 billion CFUs of this combination daily to the infant for 6 months reduces the odds of developing atopic dermatitis by up to 77% before 18 months of age when compared with no probiotic (111015).
Atopic disease. Although there has been interest in using oral Bifidobacterium breve for preventing and treating atopic disease, there is insufficient reliable information about the clinical effects of B. breve for this use.
Celiac disease. Although there has been interest in using oral Bifidobacterium breve for celiac disease, there is insufficient reliable information about the clinical effects of B. breve for this condition.
Chemotherapy-related infection. Although there has been interest in using oral Bifidobacterium breve for preventing chemotherapy-related infections, there is insufficient reliable information about the clinical effects of B. breve for this purpose.
Clostridioides difficile infection. Although there has been interest in using oral Bifidobacterium breve for C. difficile infection, there is insufficient reliable information about the clinical effects of B. breve for this condition.
Cognitive impairment. It is unclear if oral Bifidobacterium breve is beneficial for cognitive impairment. Details: Clinical research in older adults with suspected mild cognitive impairment shows that taking B. breve A1 (MCC1274) 20 billion colony-forming units daily for 16 weeks improves some measures of cognitive function, including immediate and delayed memory, as well as visual spatial ability, by moderate amounts when compared with placebo. However, there was no effect on language or attention (103447). However, taking the same dose for 24 weeks does not improve most measures of cognitive function (111002).
Colic. It is unclear if oral Bifidobacterium breve is beneficial for colic. Details: Preliminary clinical research in infants with colic shows that adding B. breve CECT7263 200 million colony-forming units (CFUs) daily, or a combination of B. breve with Limosilactobacillus fermentum CECT5716 as 100 million CFUs each daily, to human milk, formula, or water for 28 days reduces the time spent crying per week by approximately 160-200 minutes from baseline. Taking B. breve is at least as effective as taking simethicone 20 mg four times daily (105150). Other clinical research shows that taking B. breve B632 and BR03 100 million CFUs each daily for 3 months modestly reduces daily crying duration when compared with taking placebo (111010). B. breve has also been investigated for colic prevention. Clinical research in infants without colic at baseline shows that adding B. breve CECT7263 10 million CFUs per gram to formula modestly reduces the number of infants crying more than three hours daily when compared with a control formula. At 6 weeks of age, 12% of infants taking formula supplemented with B. breve cried more than 3 hours daily, compared with 29% of those using the control formula. At 4 months of age, frequency of crying more than 3 hours daily was low and not significantly different between groups (105151). However, this study was not specifically designed to examine the effects of B. breve on colic frequency as the infants did not have colic at baseline.
Constipation. Most early research shows that oral Bifidobacterium breve seems to be beneficial for constipation. Details: Preliminary clinical research in children aged 3-16 years with functional constipation shows that taking a specific B. breve powder (Yakult, Yakult Honsha Co., Ltd.) 1-100 billion colony-forming units (CFUs) daily for 4 weeks increases defecation frequency by about 4 times per week, decreases episodes of fecal incontinence by about 7.5 episodes per week, and improves stool consistency and episodes of abdominal pain (17726). Multi-strain probiotics containing bifidobacteria have also been evaluated for constipation. In children with chronic constipation, preliminary clinical research shows that taking a combination of B. breve M-16 V, Bifidobacterium longum M-63, and B. longum BB536 daily for 8 weeks in addition to polyethylene glycol (PEG), does not improve symptoms or increase the rate of clinical remission when compared with PEG alone (107600). However, one meta-analysis of clinical research in adults with functional constipation shows that taking B. breve DSM 16604 and Lactiplantibacillus plantarum LMG P-21021 as 5 billion CFUs total daily for 30 days improves bowel movement frequency by about 1.5 stools weekly when compared with placebo (95342). Also, a small clinical trial shows that taking a specific combination product (ID-HWS1000) containing Lacticaseibacillus rhamnosus IDCC 3201, L. plantarum IDCC 3501, Lacticaseibacillus casei IDCC 3451, Bifidobacterium animalis subsp. lactis IDCC 4301, Bifidobacterium breve IDCC 4401, Lactococcus lactis IDCC 2301, xylooligosaccharide, and dietary fiber as nondigestible maltodextrin, oat fiber, and psyllium husk fiber modestly increases stool frequency and improves symptoms of functional constipation in adults when compared with placebo (107517).
Depression. It is unclear if oral Bifidobacterium breve is beneficial for depression. Details: A small clinical trial in patients with major depressive disorder shows that taking B. breve CCFM1025 10 billion colony-forming units (CFUs) daily for 4 weeks modestly improves symptoms of depression when compared with placebo (107602).
Diabetes. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients for various forms of diabetes; its effect when used alone is unclear. Details: One small clinical study in patients with type 2 diabetes shows that taking a specific combination product (Familact probiotics, ZistTakhmir Co.) containing B. breve and other probiotics daily for 6 weeks does not reduce fasting blood glucose or plasma insulin levels when compared with placebo. This product contains B. breve 30 billion colony-forming units (CFUs), B. longum 7 billion CFUs, Lactobacillus acidophilus 2 billion CFUs, Lacticaseibacillus casei 7 billion CFUs, Lactocaseibacillus rhamnosus 1.5 billion CFUs, Lactobacillus delbrueckii subsp. bulgaricus 200 million CFUs, and Streptococcus thermophilus 1.5 billion CFUs (99790). In adults with gestational diabetes, one clinical study shows that taking a specific product (Visbiome, ExeGi Pharma) containing B. breve and various other probiotics as a total of 112.5 billion CFUs twice daily for 8 weeks does not affect levels of fasting blood glucose or glycated hemoglobin (HbA1c) when compared with placebo. However, there were small improvements in insulin levels and insulin resistance (107549). A combination probiotic containing B. breve has also been evaluated in children 2-12 years of age with new-onset type 1 diabetes. One clinical study shows that taking Visbiome as 112.5 billion CFUs daily for 3 months modestly decreases HbA1c and insulin requirements when compared with placebo. Also, about three times as many children achieved remission, defined as insulin requirements of less than 0.5 U/kg daily and HbA1c levels of less than 7%. However, C-peptide levels and the maintenance of residual pancreatic beta-cell function were not affected when compared with placebo (107497). It is unclear if any benefits are due to B. breve, other probiotics, or the combinations.
Diarrhea. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in children with dysentery being treated with ceftriaxone shows that taking a specific combination probiotic sachet (Kidilact, Zisttakhmir Company) containing B. breve, Lacticaseibacillus casei, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Lactobacillus delbrueckii subsp. bulgaricus, Bifidobacterium longum, and Streptococcus thermophilus daily for 5 days modestly reduces the duration of diarrhea, hospitalization, and blood in diarrhea when compared with control (102417). A large clinical trial in infants aged 4-6 months shows that taking an infant formula fermented with B. breve C50 and Streptococcus thermophilus 065 (Calisma) for about 5 months does not affect the incidence or duration of diarrhea episodes when compared with a standard infant formula. However, there was a modest reduction in severity of diarrhea episodes, based on reductions in proportions of infants with dehydration, consultations with medical providers, and need for oral rehydration (111106). This formula did not provide live B. breve.
Exercise-induced muscle soreness. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in resistance-trained males shows that taking B. breve BR03 and Streptococcus thermophilus FP4 as 10 billion colony-forming units total daily for 3 weeks prior to resistance training modestly attenuates range of motion decrements, but does not seem to significantly decrease overall muscle soreness, when compared with placebo (95415).
Helicobacter pylori. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In adults with H. pylori infection and peptic ulcer disease, adding a combination product containing seven strains of probiotics (Balance by Protexin Co) daily for 14 days to quadruple therapy with omeprazole, bismuth subcitrate, amoxicillin, and clarithromycin does not improve H. pylori eradication or symptoms when compared with quadruple therapy alone. This product provided B. breve, Lacticasebacillus casei, L acticasebacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus delbrueckii subsp. bulgaricus, Bifidobacterium longum, and Streptococcus thermophilus (90291).
Irritable bowel syndrome (IBS). Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One clinical study shows that taking a specific combination product (Visbiome, ExeGi Pharma) containing B. breve and other probiotics as 450 billion CFUs daily for 8 weeks decreases bloating in patients with diarrhea-predominant IBS (IBS-D) (11379). However, adding this product as 900 billion CFUs daily to a sham diet or a low-FODMAP diet for 4 weeks does not improve IBS symptoms when compared with placebo (98741). Other clinical research shows that taking a different product (Duolac Care) containing Lactobacillus acidophilus, Lactiplantibacillus plantarum, Lacticaseibacillus rhamnosus, Bifidobacterium breve, Bifidobacterium animalis subsp. lactis, Bifidobacterium longum, and Streptococcus thermophilus twice daily for 4 weeks can relieve symptoms in 72% of patients with IBS (95353). In addition, a clinical study in patients with IBS-D shows that taking a specific combination probiotic (NordBiotic, MBM Biotix) containing B. breve BB010, Lactobacillus acidophilus LA120, Lacticaseibacillus rhamnosus LR110, Lacticaseibacillus paracasei LPC100, Lacticaseibacillus casei LC130, Lactiplantibacillus plantarum LP140, B. longum BL020, Bifidobacterium bifidum BF030, Bifidobacterium animalis subsp. lactis BL040, and Streptococcus thermophilus ST250 as 2.5 billion CFUs total twice daily for 8 weeks improves overall symptom severity, as well as pain severity, pain frequency, and quality of life, when compared with placebo. Symptom severity was rated as mild by approximately 60% of those taking the probiotic mixture, compared with 30% of those taking placebo (107516).
Metabolic syndrome. Although there has been interest in using oral Bifidobacterium breve for metabolic syndrome, there is insufficient reliable information about the clinical effects of B. breve for this condition.
Necrotizing enterocolitis (NEC). It is unclear if oral Bifidobacterium breve is beneficial for preventing NEC. Details: One large, well-designed clinical study in preterm infants shows that taking B. breve BBG-001 up to about 90 billion colony-forming units daily in formula does not reduce the risk of NEC when compared with placebo (92256). In a systematic review, four studies show that using B. breve does not reduce the incidence of NEC in most infants. However, in one of the included studies, although there was no effect on the incidence of NEC stage 2 in the total group or in infants born at less than 28 weeks' gestation, the incidence was reduced in infants born at less than 34 weeks' gestation. Also, other preliminary clinical research shows that giving B. breve alone or with Lacticaseibacillus casei reduces the incidence of NEC (107592,107595).
Nonalcoholic fatty liver disease (NAFLD). Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with NAFLD shows that taking two sachets daily for 3 months of a specific combination product (VSL#3) containing B. breve and other probiotics does not affect body mass index or most glycemic or lipid parameters when compared with taking placebo. However, there was a modest decrease in triglyceride levels and liver enzymes (111009).
Obesity. It is unclear if oral Bifidobacterium breve is beneficial for obesity. Details: Clinical research in children aged 6-18 years with obesity and insulin resistance shows that adding B. breve BR03 (DSM 16604) and B632 (DSM 24706) 1 billion colony-forming units (CFUs) each daily for 8 weeks to advice on the Mediterranean diet and exercise modestly improves insulin sensitivity when compared with placebo. However, there was no difference between groups in body mass index (BMI) or blood pressure when compared with diet and exercise advice alone (107598). Additional clinical research in overweight, but non-obese, adults based on BMI shows that taking B. breve B-3 5 billion CFUs daily for 12 weeks modestly reduces body fat mass and waist and hip circumference when compared with taking placebo. However, there was no effect on body fat percentage or lipid endpoints (111003).
Postoperative recovery. Although there has been interest in using oral Bifidobacterium breve for improving postoperative recovery, there is insufficient reliable information about the clinical effects of B. breve for this purpose.
Pouchitis. Oral Bifidobacterium breve has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that continuous treatment with a specific combination product (Visbiome, ExeGi Pharma) containing B. breve and other probiotics as 6 grams (300-500 billion live bacteria per gram) daily for up to a year seems to maintain remission of pouchitis in 85% of patients (6087,12769).
Radiation-induced diarrhea. Although there has been interest in using oral Bifidobacterium breve for preventing radiation-induced diarrhea, there is insufficient reliable information about the clinical effects of B. breve for this purpose.
Respiratory tract infections. Although there has been interest in using oral Bifidobacterium breve for preventing respiratory tract infections, there is insufficient reliable information about the clinical effects of B. breve for this purpose.
Rotaviral diarrhea. Although there has been interest in using oral Bifidobacterium breve for rotaviral diarrhea, there is insufficient reliable information about the clinical effects of B. breve for this condition.
Short bowel syndrome. Although there has been interest in using oral Bifidobacterium breve for short bowel syndrome, there is insufficient reliable information about the clinical effects of B. breve for this condition.
Ulcerative colitis. It is unclear if oral Bifidobacterium breve is beneficial for ulcerative colitis. Details: Some clinical research has evaluated B. breve-containing probiotics for increasing remission rates in patients with ulcerative colitis. The best evidence is for a specific combination product (Visbiome, ExeGi Pharma). Doses of 3 grams (equivalent to 900 billion colony-forming units (CFUs)) once or twice daily has been used in combination with conventional treatment. In children aged 1-16 years, doses of 450-1800 billion CFUs for up to one year have been used (3261,14370,14371,16841,95337). A meta-analysis of clinical research shows that taking this probiotic can increase remission rates by about 1.7-fold when compared with placebo in adults and children with active ulcerative colitis (95337). There is also evidence that it is beneficial for improving remission rates in patients who do not adequately respond to conventional treatment (14371). Additionally, some preliminary clinical research shows that this specific product, taken as an adjunct to standard maintenance therapy, might help prevent relapse (3261,16841). Other preliminary clinical research shows that taking Visbiome or a fermented milk (Yakult, Yakult Honsha Co., Ltd.) containing B. breve, Bifidobacterium bifidum, and Lactobacillus acidophilus as an adjunct to standard maintenance therapy might help prevent relapse in ulcerative colitis patients (3261,12775,14338,16841). However, other research shows that taking B. breve Yakult is not beneficial for preventing ulcerative colitis relapse (98740). More evidence is needed to rate Bifidobacterium breve for these uses.

Acute radiation syndrome. It is unclear if oral Bifidobacterium longum is beneficial for acute radiation syndrome. Details: A small clinical study shows that antibiotic-resistant B. longum can help improve short-term survival in the treatment of radiation sickness. In combination with prophylactic antibiotics, B. longum appears to inhibit colonization and overgrowth of intestinal opportunistic pathogens, preventing post-irradiation sepsis. This study used B. longum 10 billion colony-forming units daily in 10 mL of milk for 30 days, starting approximately 10 days after irradiation (3457).
Age-related cognitive decline. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients over 65 years of age shows that taking a sachet (Morinaga Milk Industry Co., Ltd) containing lyophilized powder of B. longum BB536 and M-63, along with B. breve M-16V and B-3 as 12.5 billion colony-forming units each with water daily for 12 weeks does not improve cognition as measured on the Montreal Cognitive Assessment (MoCA) when compared with placebo (102412). While the results of this study may have been limited by the small population size, a larger clinical study in adults ages 50-80 years with subjective memory complaints also shows that using the same product for the same duration does not improve cognition when compared with placebo (102414).
Antibiotic-associated diarrhea. It is unclear if oral Bifidobacterium longum is beneficial for preventing antibiotic-associated diarrhea (AAD); the available research is conflicting. Details: One preliminary clinical study shows that taking B. longum can reduce stool frequency, abdominal discomfort, and stool clostridial spore count when used in patients concurrently taking erythromycin (1233). However, other research shows that taking B. longum with clindamycin does not significantly reduce diarrhea (14334). A small clinical trial in children aged 5 months to 16 years shows that taking a combination of B. longum PL03, Lacticaseibacillus rhamnosus KL53A, and Lactiplantibacillus plantarum PL02 twice daily during antibiotic treatment does not reduce the rate of AAD when compared with placebo. However, there was a modest reduction in the number of stools each day (107553).
Athletic performance. It is unclear if oral Bifidobacterium longum is beneficial for athletic performance. Details: In athletes, preliminary clinical research shows that taking B. longum OLP-01 15 billion colony-forming units in three divided doses daily for 5 weeks with training and de-training does not affect the distance run in 12 minutes when compared with placebo (103446).
Atopic dermatitis (eczema). Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Research evaluating B. longum-containing probiotics for preventing atopic dermatitis has been mixed. One clinical study shows that taking a combination of B. longum plus Lacticaseibacillus rhamnosus or Lacticaseibacillus paracasei, beginning about 2 months before expected delivery and continuing through breastfeeding until the infant is 2 months old, reduces the risk of eczema in the infant (90285). In addition, in children ages 4-17 years, taking 1 billion CFUs of a 1:1:1 combination of B. longum CECT 7347, Lacticaseibacillus casei CECT 9104, and Bifidobacterium animalis subsp. lactis CECT 8145 for 12 weeks modestly reduces symptom severity and the need for topical corticosteroids when compared with placebo (107531). However, in infants with a family history of allergic disease, giving human milk containing B. longum BL999 10 million CFUs and L. rhamnosus 20 million CFUs daily for the first 6 months of life does not seem to reduce the incidence of eczema or atopic sensitization (35396).
Cancer. Although there has been interest in using oral Bifidobacterium longum for cancer prevention or treatment, there is insufficient reliable information about the clinical effects of B. longum for this condition.
Celiac disease. It is unclear if oral Bifidobacterium longum is beneficial for celiac disease. Details: Preliminary clinical research in children aged 2-17 years with celiac disease shows that taking B. longum CECT 7347 1 billion colony-forming units daily along with a gluten-free diet for 3 months does not improve gastrointestinal symptoms, including diarrhea, constipation, abdominal pain, or vomiting, when compared with placebo (92266).
Chemotherapy-related infection. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with leukemia receiving chemotherapy shows that taking B. longum in combination with Lactobacillus acidophilus (Morinaga Bifidus), with or without Enterococcus faecalis (Levenin), does not reduce the risk of Candida infection when compared to control (35434).
Clostridioides difficile infection. Although there has been interest in using oral Bifidobacterium longum for C. difficile infection, there is insufficient reliable information about the clinical effects of B. longum for this condition.
Colic. Although there has been interest in using oral B. longum for colic, there is insufficient reliable information about the clinical effects of B. longum for this condition.
Constipation. It is unclear if oral Bifidobacterium longum is beneficial for constipation. Details: B. longum BB536 in doses of 2-20 billion colony-forming units (CFUs) has been evaluated for constipation in adults, but results are conflicting and modest at best (35413,35424). Multi-strain probiotics containing B. longum have also been evaluated. Clinical research in adults with chronic constipation shows that taking a multi-strain probiotic (Hexbio) containing B. longum, Bifidobacterium bifidum, Lactobacillus acidophilus, Lacticaseibacillus casei, and Lactobacillus delbrueckii subsp. lactis 30 billion CFUs twice daily for 7 days increases the number of weekly bowel movements by about 2 when compared with placebo (90266). However, in children with chronic constipation, preliminary clinical research shows that taking a combination of B. longum M-63, B. longum BB536, and B. breve M-16 V daily for 8 weeks in addition to polyethylene glycol (PEG) does not improve symptoms or increase the rate of clinical remission when compared with PEG alone (107600).
Coronavirus disease 2019 (COVID-19). Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small, retrospective study in patients with severe COVID-19 symptoms shows that taking a combination of probiotics in three divided doses daily modestly reduces the duration of diarrhea when compared to standard treatments alone. The probiotic treatment consisted of B. longum 60 million colony-forming units (CFUs), Streptococcus thermophilus 6 million CFUs, and Lactobacillus delbrueckii subsp. bulgaricus 6 million CFUs, given in three divided doses daily (107200).
Depression. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In treatment-naïve patients with moderate depression, preliminary clinical research shows that taking 0.3 billion colony-forming units (CFUs) of B. longum R0175 in combination with 2.7 billion CFUs of Lactobacillus helveticus R0052 (Cerebiome, Lallemand Health Solutions Inc.) daily for 8 weeks modestly improves symptoms of depression and sleep quality when compared with baseline (105129).
Diabetes. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study in patients with type 2 diabetes shows that taking a specific combination product (Familact probiotics, ZistTakhmir Co.) containing B. longum and other probiotic bacteria daily for 6 weeks does not reduce fasting blood glucose or plasma insulin levels when compared with placebo. This product contains B. longum 7 billion colony-forming units (CFUs), Bifidobacterium breve 30 billion CFUs, Lactobacillus acidophilus 2 billion CFUs, Lacticaseibacillus casei 7 billion CFUs, Lactocaseibacillus rhamnosus 1.5 billion CFUs, Lactobacillus delbrueckii subsp. bulgaricus 200 million CFUs, and Streptococcus thermophilus 1.5 billion CFUs (99790). In adults with gestational diabetes, one clinical study shows that taking a specific combination product (Visbiome, ExeGi Pharma) containing B. breve and various other probiotics as a total of 112.5 billion CFUs twice daily for 8 weeks does not affect levels of fasting glucose or glycated hemoglobin (HbA1c) when compared with placebo. However, there were small improvements in insulin levels and insulin resistance (107549). Also, a large clinical trial shows that taking B. longum sp54 cs at least 1.5 billion CFUs daily, L. acidophilus LA1 at least 7.5 billion CFUs daily, and Bifidobacterium bifidum sp9 cs at least 6 billion CFUs daily from 14-24 weeks' gestation does not reduce the incidence of gestational diabetes when compared with placebo (107520). Clinical research in children 2-12 years of age with new-onset type 1 diabetes shows that taking Visbiome as 112.5 billion CFUs daily for 3 months modestly decreases HbA1c and insulin requirements when compared with placebo. Also, about three times as many children achieved remission, which was defined as insulin requirements of less than 0.5 U/kg daily and HbA1c levels of less than 7%. However, C-peptide levels and the maintenance of residual pancreatic beta-cell function were not affected when compared with placebo (107497).
Diarrhea. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in children with dysentery being treated with ceftriaxone shows that taking a specific combination probiotic sachet (Kidilact, Zisttakhmir Company) containing B. longum, B. breve, Lacticaseibacillus casei, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Lactobacillus delbrueckii subsp. bulgaricus, and Streptococcus thermophilus daily for 5 days modestly reduces the duration of diarrhea, hospitalization, and blood in diarrhea when compared with control (102417).
Familial hypercholesterolemia. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children 6-18 years of age with high cholesterol shows that taking a probiotic containing B. longum BL04, Bifidobacterium animalis subsp. lactis MB 2409, and Bifidobacterium bifidum MB 109 daily for 12 weeks reduces total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglyceride levels by 2% to 3% and increases HDL cholesterol levels by about 2% when compared with placebo. However, these changes might not be considered clinically significant (98736).
Hepatic encephalopathy. Although there has been interest in using oral Bifidobacterium longum for hepatic encephalopathy, there is insufficient reliable information about the clinical effects of B. longum for this condition.
Helicobacter pylori. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of clinical research in adults shows that taking combination products containing both lactobacilli and bifidobacteria in conjunction with standard therapy increases the odds of H. pylori eradication by approximately 2-fold when compared with standard therapy alone. These combinations also reduce the odds of disease-related side effects by approximately 70% when compared with standard therapy alone. Six of the ten studies in the meta-analysis included B. longum, with two specifying the inclusion of two B. longum subspecies (90601). However, one clinical study has evaluated a combination product containing seven strains of probiotics in adults with H. pylori infection and peptic ulcer disease. In this study, adding this specific probiotic (Balance by Protexin Co) daily for 14 days to quadruple therapy with omeprazole, bismuth subcitrate, amoxicillin, and clarithromycin does not improve H. pylori eradication or symptoms when compared with quadruple therapy alone. This product provided B. longum, B. breve, Lacticaseibacillus casei, Lacticaseibacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus delbrueckii subsp. bulgaricus, and Streptococcus thermophilus (90291). The lack of effect might be attributed to the shorter duration of therapy or the different composition and dose of probiotics.
Hyperlipidemia. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in individuals with total cholesterol of 190 mg/dL or higher shows that taking fermented milk 375 grams containing B. longum BB536 and Lactobacillus acidophilus 145 for 4 weeks reduces low-density lipoprotein (LDL) cholesterol levels when compared with yogurt. However, high-density lipoprotein (HDL) cholesterol levels seem to be reduced as well (35401).
Irritable bowel syndrome (IBS). Although most research shows that taking Bifidobacterium longum in combination with other probiotics is beneficial for IBS, the effect of B. longum alone is unclear. Details: Some clinical research shows that consuming B. longum (35624; Align or Bifantis) in daily doses of 100 million colony-forming units (CFUs) as capsules or 1 billion CFUs as a malted milk drink for 4-8 weeks reduces abdominal pain, bloating, and bowel movement difficulty in patients with IBS within one week of treatment (13054,95392). However, not all research agrees. A meta-analysis of a small number of clinical studies shows that although this strain reduces overall symptom severity, taking B. longum does not increase the frequency of global responders or reduce abdominal pain when compared with placebo (107594). Also, although a meta-analysis of two studies shows that taking B. longum 35624 along with multiple other probiotics reduces abdominal pain and bloating/distension, a meta-analysis of three clinical trials shows that taking B. longum 35624 alone does not improve these symptoms or bowel habit satisfaction (107593). Also, one clinical trial shows that taking B. longum R0175 10 billion CFUs daily for 8 weeks does not improve symptoms of IBS when compared with placebo (103440). One clinical study shows that taking B. longum NCC3001 10 billion CFUs once daily for 6 weeks increases the percentage of patients with IBS who experience a clinically meaningful improvement in anxiety and depression symptoms by about 2-fold when compared with placebo. A clinically meaningful improvement was defined as an increase in Hospital Anxiety and Depression (HAD) scale score of at least 2 points (95417). Some research has evaluated B. longum in combination with other probiotics. One clinical study shows that taking a specific combination product (Visbiome, ExeGi Pharma) as 450 billion CFUs daily for 8 weeks decreases bloating in patients with diarrhea-predominant IBS (IBS-D) (11379). However, adding this product as 900 billion CFUs daily to a sham diet or a low-FODMAP diet for 4 weeks does not improve IBS symptoms when compared with placebo (98741). Other clinical research shows that taking a different product (Duolac Care) containing B. longum, Bifidobacterium breve, Bifidobacterium animalis subsp. lactis, Lactobacillus acidophilus, Lactiplantibacillus plantarum, Lacticaseibacillus rhamnosus, and Streptococcus thermophilus twice daily for 4 weeks can relieve symptoms in 72% of patients with IBS (95353). In addition, a clinical study in patients with IBS-D shows that taking a specific combination probiotic (NordBiotic, MBM Biotix) containing Lactobacillus acidophilus LA120, Lacticaseibacillus rhamnosus LR110, Lacticaseibacillus paracasei LPC100, Lacticaseibacillus casei LC130, and Lactiplantibacillus plantarum LP140, B. breve BB010, B. longum BL020, B. bifidum BF030, B. animalis subsp. lactis BL040, and Streptococcus thermophilus ST250 2.5 billion CFUs daily twice daily for 8 weeks improves overall symptom severity, as well as pain severity, pain frequency, and quality of life when compared with placebo. Symptom severity was rated as mild by approximately 60% of those taking the probiotic mixture, compared with 30% of those taking placebo (107516).
Japanese cedar pollinosis. It is unclear if oral Bifidobacterium longum is beneficial for this condition. Details: Some clinical research shows that taking powder containing B. longum BB536 50 billion colony-forming units twice daily for 4-13 weeks during pollen season reduces runny nose, nasal blockage, and overall symptom score when compared with placebo in patients with Japanese cedar pollen allergy (35382). However, other clinical research shows that taking this same strain daily for 13 weeks does not reduce runny nose or nasal blockage when compared with placebo (35379). There is also conflicting evidence regarding the effect of B. longum on eye symptoms, with some evidence showing no beneficial effect and other evidence suggesting reduced eye symptoms (35382,35384). Also, B. longum BB536 does not seem to improve nasal itching, sneezing, or throat symptoms associated with Japanese cedar pollinosis (35379,35382,35384).
Lactose intolerance. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In patients with persistent symptoms related to lactose intolerance despite a lactose-free diet, a small clinical trial shows that taking a combination of B. longum BB536 4 billion colony-forming units (CFUs), Lacticaseibacillus rhamnosus HN001 1 billion CFUs, and vitamin B6 1.4 mg (Zircombi) daily for 30 days modestly improves symptoms of bloating and constipation, but not abdominal pain, when compared with placebo (105153).
Necrotizing enterocolitis (NEC). It is unclear if oral Bifidobacterium longum is beneficial for NEC prevention. Details: Although some research disagrees, most clinical research and meta-analyses of clinical research show that giving bifidobacteria alone does NOT reduce the risk of NEC or all-cause mortality (92256,95344,95351,103437,105164). However, giving bifidobacteria in combination with lactobacilli or Enterococcus faecalis to preterm infants appears to reduce the risk of NEC by up to 87% and giving bifidobacteria with a prebiotic appears to reduce the risk of mortality (3162,90252,95351,102419,103437,103448,104157,105162,105164). The effects of B. longum specifically are unclear.
Nonalcoholic fatty liver disease (NAFLD). Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in patients with NAFLD shows that taking a combination product (Hexbio) containing B. longum BCMC 02129, B. longum BCMC 02120, Bifidobacteruim bifidum BMCM 02290, Lactobacillus acidophilus BCMC 12,130, Lacticaseibacillus casei BCMC 12,313, and Lactobacillus delbrueckii subsp. lactis BCMC 12,451 as 30 billion colony-forming units twice daily for 6 months has no beneficial effects on hepatic steatosis or fibrosis, liver enzyme levels, blood lipids, or fasting blood glucose levels when compared with placebo (107523).
Nonalcoholic steatohepatitis (NASH). Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with NASH shows that taking a specific combination probiotic capsule (Lactiale, Farmak) containing B. longum, Lacticaseibacillus casei, Lacticaseibacillus rhamnosus, Lactobacillus delbrueckii subsp. bulgaricus, and Streptococcus thermophilus 100 million colony-forming units in total, with fructo-oligosaccharides, once daily for 12 weeks does not improve liver enzyme levels or hepatic steatosis when compared with control (102415).
Obesity. Although there has been interest in using oral Bifidobacterium longum for weight loss, there is insufficient reliable information about the clinical effects of B. longum for this use.
Oral mucositis. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A clinical study in patients with locally advanced nasopharyngeal cancer undergoing radiochemotherapy shows that taking a specific probiotic product (Bifico, Shanghai Sine Pharmaceutical Co. Ltd.) containing B. longum, Lactobacillus delbrueckii subsp. lactis, and Enterococcus faecium three capsules twice daily for up to 7 weeks modestly reduces the incidence of severe oral mucositis when compared with placebo (102413).
Periodontitis. Although there has been interest in using oral Bifidobacterium longum for periodontitis, there is insufficient reliable information about the clinical effects of B. longum for this condition.
Postoperative infection. Although there has been interest in using oral Bifidobacterium longum for preventing postoperative infection, there is insufficient reliable information about the clinical effects of B. longum for this condition.
Pouchitis. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that continuous treatment with a specific combination product (Visbiome, ExeGi Pharma) containing B. longum and other probiotics as 6 grams (300-500 billion live bacteria per gram) daily for up to a year seems to maintain remission of pouchitis in 85% of patients (6087,12769).
Psoriasis. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with psoriasis shows that taking a mixture of probiotics for 8 weeks modestly improves overall symptoms and feelings of depression when compared with placebo. The percentage of patients achieving at least a 50% or 75% reduction in overall symptom score was 40% and 24%, respectively, in those taking the probiotic, compared with 16% and 8% of those taking placebo. Each probiotic capsule provided a total daily dose of 2.6 billion colony-forming units (CFUs) of B. longum, Bifidobacterium bifidum, Bifidobacterium animalis subsp. lactis, and Lactobacillus acidophilus (107498).
Respiratory tract infections. It is unclear if oral Bifidobacterium longum is beneficial for preventing respiratory tract infections. Details: One clinical study shows that taking B. longum R0033 3 billion colony-forming units (CFUs) daily for 6 weeks does not reduce the percentage of college students who experience at least one day of cold or flu or the overall number of cold or flu episodes when compared with placebo (90272). However, preliminary clinical research in children aged 2-6 years shows that taking B. longum B536, 5 billion CFUs daily on 5 days each week for 10 months, reduces the duration of sore throat by 46% and modestly decreases the frequency of respiratory illnesses when compared with placebo. There was also a nonsignificant trend toward reduced fever and runny nose duration in the treatment group; however, the study was not adequately powered to detect a difference in these outcomes (98738).
Rotaviral diarrhea. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in hospitalized infants with rotaviral infection shows that giving a probiotic formula containing B. longum BORI and Lactobacillus acidophilus AD031 2 billion colony-forming units per gram twice daily for 3 days reduces the duration of diarrhea by about 1.2 days when compared with placebo; however, it does not reduce the duration of fever or the frequency of diarrhea or vomiting (95334).
Ulcerative colitis. Oral Bifidobacterium longum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Some clinical research has evaluated B. longum-containing probiotics for increasing remission rates in patients with ulcerative colitis. The best evidence is for a specific combination product (Visbiome, ExeGi Pharma). Doses of 3 grams (equivalent to 900 billion colony-forming units (CFUs)) once or twice daily has been used in combination with conventional treatment. In children aged 1-16 years, doses of 450-1800 billion CFUs for up to one year have been used (3261,14370,14371,16841,95337). A meta-analysis of clinical research shows that taking this probiotic can increase remission rates by about 1.7-fold when compared with placebo in adults and children with active ulcerative colitis (95337). There is also evidence that it is beneficial for improving remission rates in patients who do not adequately respond to conventional treatment (14371). Additionally, some preliminary clinical research shows that this specific product, taken as an adjunct to standard maintenance therapy, might help prevent relapse (3261,16841). More evidence is needed to rate Bifidobacterium longum for these uses.

Diarrhea. Oral Lacticaseibacillus casei seems to be beneficial for the prevention of acute diarrhea in children, although its benefits in the treatment of acute diarrhea are unclear. Details: One large clinical study shows that taking a fermented milk product containing L. casei DN-114 001 (e.g., DanActive, Dannon) 100 million colony-forming units (CFUs) per milliliter for up to 4 months helps to prevent acute, non-rotaviral diarrhea in children ages 6-24 months (14374). A small clinical study in children with dysentery being treated with ceftriaxone shows that taking a specific combination probiotic sachet (Kidilact, Zisttakhmir Company) containing L. casei, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Lactobacillus delbrueckii subsp. bulgaricus, Bifidobacterium longum subsp. infantis, Bifidobacterium breve, and Streptococcus thermophilus daily for 5 days modestly reduces the duration of diarrhea, hospitalization, and blood in diarrhea when compared with control (102417). Although The European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388), both guidelines note that most evidence is low quality.
Upper respiratory tract infections (URTI). Oral Lacticaseibacillus casei seems to prevent upper respiratory tract infections (URTIs) in adults. Details: Clinical research in healthy middle-aged office workers shows that drinking fermented milk containing L. casei Shirota (LCS, Yakolt) 100 billion colony-forming units (CFUs) daily for 12 weeks reduces the rate of URTIs by 26% when compared with control milk. Patients drinking this product also experienced an average 2.2-day shorter duration of symptoms (98426).

Exercise-induced respiratory infections. Oral Lacticaseibacillus casei does not seem to be beneficial for preventing respiratory infections related to exercise. Details: Clinical research in endurance athletes shows that taking a probiotic supplement containing L. casei Shirota (LCS, Yakult) 65 billion colon-forming units (CFUs) twice daily for 20 weeks does not reduce the risk of developing an upper respiratory tract infection when compared with placebo. Taking this probiotic also does not reduce the duration or severity of respiratory infections in this population (98431).

Antibiotic-associated diarrhea. Oral Lacticaseibacillus casei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that specific L. casei-containing combination products may be beneficial for preventing antibiotic-associated diarrhea. These combination products include Bio-K+ CI1285, providing L. casei LBC80R, Lactobacillus acidophilus CL1285 and Lacticaseibacillus rhamnosus CLR2 as 100 billion colony-forming units (CFUs) daily (25494,95402,95403) and Actimel (Danone), providing L. casei, Lactobacillus delbrueckii subsp. bulgaricus, and Streptococcus thermophilus (16740).
Antituberculosis treatment-associated adverse effects. It is unclear if oral Lacticaseibacillus casei is beneficial for preventing adverse effects associated with antituberculosis treatment. Details: Preliminary clinical research shows that taking L. casei Shirota 10 billion or 20 billion colony-forming units (CFUs) daily during standard antituberculosis treatment does not reduce the incidence of liver injury when compared with antituberculosis treatment alone. However, there was a modest decrease in the incidence of elevated alkaline phosphatase in patients taking 20 billion CFUs daily and a modest decrease in the incidence of elevated bilirubin in patients taking 10 billion CFUs daily. There was no effect on other liver markers (107509). Other preliminary clinical research shows that taking this same dose daily for 2 months during standard antituberculosis treatment reduces the rate of any gastrointestinal adverse event to 29% to 38% of patients, compared with 50% of those taking antituberculosis treatment alone. In addition, the duration of symptoms was shorter. However, when individual gastrointestinal adverse events were evaluated, only the incidence and duration of vomiting and appetite loss were reduced; the incidence of nausea, diarrhea, flatulence, and constipation were unaffected (107542).
Atopic dermatitis (eczema). Oral Lacticaseibacillus casei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In children under two years of age with atopic dermatitis who are on a cow's milk protein elimination diet, clinical research shows that taking a specific mixture (Latopic, Biomed S.A.) providing 1 billion colony-forming units (CFUs) of L. casei ŁOCK 0919 50%, Lacticaseibacillus rhamnosus ŁOCK 0900 25%, and L. rhamnosus ŁOCK 0908 25% for 3 months increases the odds of a 30% or greater improvement in symptom scores by about 2.6-fold when compared with placebo. However, there was no difference in the absolute symptom scores between groups. Beneficial effects of this combination were greater in children confirmed to have allergen sensitization (107510). Other clinical research in children ages 4-17 years shows that taking 1 billion CFUs of a 1:1:1 combination of L. casei CECT 9104, Bifidobacterium lactis CECT 8145, and Bifidobacterium longum CECT 7347 for 12 weeks modestly reduces symptom severity and the need for topical corticosteroids when compared with placebo (107531).
Cancer. Although there has been interest in using oral Lacticaseibacillus casei for cancer prevention or treatment, there is insufficient reliable information about the clinical effects of L. caseis for this condition.
Clostridioides difficile infection. Some early research suggests that oral Lacticaseibacillus casei may be beneficial for preventing a first C. difficile infection. However, the quality of evidence is generally poor, and taking oral L. casei does not seem to be beneficial for the prevention of C. difficile recurrence. Details: Evidence from clinical and observational research investigating the effect of L. casei on C. difficile occurrence or recurrence is weak. Most studies use this species in combination with one or more additional probiotic species, including a specific product (Bio-K+ Cl1285) providing L. casei LBC80R and Lactobacillus acidophilus CL1285 and a specific product (Bio-K+ 50 Billion; Bio-K Plus International) providing L. casei LBC80R, L. acidophilus CL1285, and Lacticaseibacillus rhamnosus CLR2 as 50 or 100 billion CFUs daily (25494,90231,90934,95369,95403,107529). Observational research has found that providing a specific combination (Bio-K+ 50 Billion; Bio-K Plus International) of L. casei LBC80R, L. rhamnosus CLR2, and L. acidophilus CL1285 as 50-100 billion colony-forming units (CFUs) daily for 5 days to patients who are on antibiotics for at least 2 days reduces the hospital-wide incidence of C. difficile by approximately 40%. The incidence rate was decreased by at least 50% in the highest risk individuals taking this combination (107529). Current guidelines from the Infectious Diseases Society of America (IDSA) state that there is insufficient information to recommend administration of probiotics for the primary prevention of C. difficile-associated diarrhea (107538).
Constipation. It is unclear if oral Lacticaseibacillus casei is beneficial for constipation. Details: Meta-analyses of two or three clinical trials in adults with functional constipation show that taking L. casei Shirota 6.5-30 billion CFUs daily for 4 weeks does not appear to improve gut transit time or increase the number of stools (95342). However, combinations of probiotics containing L. casei appear to increase stool frequency and improve symptoms of functional constipation in adults. These combinations include Hexbio, containing L. casei, Lactobacillus acidophilus, Lactobacillus delbrueckii subsp. lactis, Bifidobacterium bifidum, Bifidobacterium longum, and Bifidobacterium longum subsp. infantis 30 billion CFUs twice daily for 7 days (90266), and ID-HWS1000, containing L. casei IDCC 3451, Lactiplantibacillus plantarum IDCC 3501, Lacticaseibacillus rhamnosus IDCC 3201, Bifidobacterium animalis subsp. lactis IDCC 4301, Bifidobacterium breve IDCC 4401, Lactococcus lactis IDCC 2301, xylooligosaccharide, and dietary fiber as nondigestible maltodextrin, oat fiber, and psyllium husk fiber (107517).
Depression. Oral Lacticaseibacillus casei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with major depression shows that taking L. casei, Lactobacillus acidophilus, and Bifidobacterium bifidum daily for 8 weeks reduces symptoms of depression measured on the Beck Depression Inventory (BDI) when compared with placebo (99780). However, the validity of the results from this study is limited by incomplete reporting. For example, patient baseline BDI scores were not reported.
Diabetes. It is unclear if oral Lacticaseibacillus casei is beneficial for treatment of type 2 or gestational diabetes. Details: In patients with gestational diabetes, clinical research shows that taking a combination of freeze-dried L. casei, Lactobacillus acidophilus, and Bifidobacterium bifidum each as 2 billion colony-forming units (CFUs) per gram daily for 6 weeks improves fasting blood glucose levels and glycemic control when compared with placebo (95416,98430). However, it is unclear if any beneficial effects are related to L. casei, L. acidophilus, Bifidobacterium bifidum, or the combination. Limited evidence from mainly small clinical trials has also assessed the effects of L. casei for type 2 diabetes. In one study, taking L. casei 100 million CFUs daily for 8 weeks reduces fasting blood glucose by about 28 mg/dL when compared with placebo. There was no effect on glycated hemoglobin; however, the duration was inadequate to demonstrate an effect (99786). In another study, taking a specific product (Familact) containing L. casei and six other probiotic strains daily for 6 weeks reduces fasting blood glucose, but does not affect plasma insulin, when compared with placebo (99790).
Fractures. It is unclear if oral Lacticaseibacillus casei is beneficial for the healing of fractures. Details: A clinical study in elderly adults with distal radius fracture shows that consuming 100 mL of skim milk containing L. casei Shirota 12 billion colony-forming units twice daily for 3 months modestly improves hand function, pain, and daily life activities when compared with skimmed milk placebo (102407). This study is limited by the fact that, although subjective measures showed improvement, there was no consistent improvement in objective measures.
Helicobacter pylori. It is unclear if oral Lacticaseibacillus casei is beneficial for H. pylori eradication in adults or children. Details: Clinical research in adults shows that taking L. casei along with six other probiotics in conjunction with bismuth quadruple therapy does not seem to improve H. pylori eradication rates when compared with placebo and bismuth quadruple therapy (90291). Also, taking a combination of L. casei and Lactobacillus acidophilus without any standard H. pylori therapies does not improve H. pylori eradication rates (12766). However, a clinical study in children shows that taking a fermented milk product containing L. casei DN-114 001 for 14 days along with triple therapy comprised of omeprazole, amoxicillin, and clarithromycin for 7 days improves the H. pylori eradication rate to approximately 85%, compared with 61% of those given triple therapy alone (107544).
HIV/AIDS. Although there has been interest in using oral Lacticaseibacillus casei for HIV/AIDS, there is insufficient reliable information about the clinical effects of lactobacillus for this condition.
Hypertension. It is unclear if oral Lacticaseibacillus casei is beneficial for lowering blood pressure. Details: A meta-analysis of 18 clinical trials shows that taking various species of lactobacilli as 100 million to 1.5 trillion colony-forming units daily for 3-24 weeks reduces systolic and diastolic blood pressure by 3 mmHg and 1.5 mmHg, respectively, when compared with placebo in various populations. However, sub-group analyses of three clinical trials show that these benefits do not occur in clinical research investigating the effects of L. casei, specifically (105135).
Irritable bowel syndrome (IBS). Oral Lacticaseibacillus casei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A clinical study in patients with diarrhea-predominant IBS shows that taking a specific multi-species probiotic (NordBiotic, MBM Biotix) containing L. casei LC130, Lacticaseibacillus rhamnosus LR110, Lacticaseibacillus paracasei LPC100, Lactobacillus acidophilus LA120, Lactiplantibacillus plantarum LP140, Bifidobacterium breve BB010, Bifidobacterium longum BL020, Bifidobacterium bifidum BF030, Bifidobacterium animalis subsp. lactis BL040, and Streptococcus thermophilus ST250 as 2.5 billion colony-forming units (CFUs) total twice daily for 8 weeks improves overall symptom severity, as well as pain severity, pain frequency, and quality of life, when compared with placebo. Symptom severity was rated as mild by approximately 60% of those taking the probiotic mixture, compared with 30% of those taking placebo (107516). However, clinical research shows that taking another multi-species combination of L. casei LBC80R, L. acidophilus CL1285, and L. rhamnosus CLR2 50 billion CFUs each daily for 3 months does not improve symptoms in patients with IBS when compared with placebo (99789).
Lyme disease. Although there has been interest in using oral Lacticaseibacillus casei for Lyme disease, there is insufficient reliable information about the clinical effects of lactobacillus for this condition.
Necrotizing enterocolitis (NEC). It is unclear if oral Lacticaseibacillus casei is beneficial for NEC. Details: Most meta-analyses of clinical research show that giving lactobacilli enterally reduces the risk of NEC and/or severe NEC in preterm, mainly very low birth weight (VLBW), infants. Some meta-analyses support the use of lactobacilli in combination with bifidobacteria, as opposed to lactobacilli alone for reducing the risk of NEC. However, the effects of L. casei specifically are unclear (95344,95351,103437,103445,104157,105162,105164).
Nonalcoholic fatty liver disease (NAFLD). Oral Lacticaseibacillus casei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in adults with NAFLD shows that taking a combination of L. casei BCMC 12,313, Lactobacillus acidophilus BCMC 12,130, Lactobacillus delbrueckii subsp. lactis BCMC 12,451, Bifidobacterium bifidum BCMC 02290, Bifidobacterium longum subsp. infantis BCMC 02129, and Bifidobacterium longum BCMC 02120 as 30 billion colony-forming units twice daily for 6 months has no beneficial effects on hepatic steatosis or fibrosis or on levels of liver enzymes, blood lipids, or fasting blood glucose, when compared with placebo (107523).
Polycystic ovary syndrome (PCOS). Oral Lacticaseibacillus casei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In patients with PCOS, clinical research shows that taking a combination of L. casei T2 (IBRC-M10783), Lactobacillus acidophilus T16 (IBRC-M10785), and Bifidobacterium bifidum T1 (IBRC-M10771) as 2 billion colony-forming units each, plus inulin 800 mg, daily for 12 weeks modestly reduces serum insulin and triglyceride levels and improves insulin resistance and insulin sensitivity when compared with placebo. However, it does not alter cholesterol or fasting blood glucose levels (105159).
Pregnancy-induced nausea and vomiting. Oral Lacticaseibacillus casei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial shows that taking probiotics during pregnancy reduces the severity and duration of nausea and vomiting by 16% to 54%. There was also a small benefit on stool hardness. A specific probiotic (Probiotics 10, Nature's Bounty) was taken as 2 capsules daily for two back-to-back cycles comprised of six days with probiotics and two days without. Each capsule contained a total of 10 billion colony-forming units (CFUs) of L. casei Lc-11, Lactiplantibacillus plantarum 299v and DSM 15312, Lactobacillus delbrueckii subsp. bulgaricus Lb-87, Lacticaseibacillus paracasei DSM 13434 and Lpc-37, Ligilactobacillus salivarius Ls-33, Levilactobacillus brevis Lbr-35, Lactobacillus acidophilus La-14, and Bifidobacterium animalis subsp. lactis Bl-04, along with inulin 200 mg (107199).
Rheumatoid arthritis (RA). Small clinical studies suggest that taking Lacticaseibacillus casei might be beneficial for RA. Details: Two small clinical studies in patients with RA show that taking L. casei 01 as 100 million colony-forming units daily for 8 weeks reduces tender and swollen joints and increases the number of patients who experience moderate symptom improvement when compared with placebo (90230,90297). However, one small clinical study in patients with moderate-to-severe RA shows that taking capsules containing freeze-dried strains of L. casei, Lactobacillus acidophilus, and Bifidobacterium bifidum daily for 8 weeks does not reduce RA severity, the number of tender or swollen joints, or joint pain when compared with placebo (95418).
Rotaviral diarrhea. It is unclear if Lacticaseibacillus casei is beneficial for rotaviral diarrhea. Details: Although the World Gastroenterology Organization has not made a recommendation (98471), the European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388). However, these guidelines note that most evidence is low quality and is not specific to rotavirus infection. Furthermore, these guidelines were released prior to the publication of the most recent, high-quality studies showing no benefit with the use of certain probiotics (98427,98428). Research on the use of L. casei, specifically, for this purpose is lacking.
Short bowel syndrome. Although there has been interest in using oral Lacticaseibacillus casei for short bowel syndrome, there is insufficient reliable information about the clinical effects of L. casei for this condition.
Small intestinal bacterial overgrowth (SIBO). It is unclear if oral Lacticaseibacillus casei is beneficial for the treatment of SIBO. Details: One preliminary clinical study in adults with irritable bowel syndrome and a recent diagnosis of SIBO shows that consuming 65 mL of a specific product (Yakult, Yakult Ltd.) providing 6.5 billion colony-forming units (CFUs) of L. casei Shirota by mouth daily for 6 weeks modestly improves flatulence, but not other symptoms, when compared to baseline (91144). Also, a small clinical study in children with chronic diarrhea due to SIBO shows that taking a combination of lyophilized L. casei 1.5 grams and Lactobacillus acidophilus 1.5 grams by mouth twice daily for 21 days decreases average daily stools by 1.5, but does not improve other symptoms, when compared with placebo (91143). Disparate study findings may be due to many factors, including differences in patient populations evaluated and use of different probiotic formulations. More evidence is needed to rate Lacticaseibacillus casei for these uses.

LACTICASEIBACILLUS PARACASEI (Lactobacillus paracasei)

Allergic rhinitis (hay fever). Oral live or heat-killed Lacticaseibacillus paracasei seems to improve some symptoms of allergic rhinitis in adults and children. Details: Clinical research in adults with persistent allergic rhinitis due to grass pollen despite treatment with loratadine shows that taking L. paracasei LP-33 as 2 billion colony-forming units (CFUs) daily for 5 weeks can improve quality of life by almost 18% when compared with placebo. The improvement in quality of life appears to be related to improvements in eye-related symptoms, but not nasal symptoms (90242). In children with perennial allergic rhinitis due to dust mites, taking L. paracasei LP-33 10 billion CFUs daily for 30 days improves quality of life related to overall symptom severity or level of bother by 28% and 23%, respectively, when compared to placebo. However, quality of life related specifically to nasal and eye-related symptoms was not improved when compared with placebo (107532). Clinical research in children aged 5 years and older with perennial allergic rhinitis due to dust mites shows that taking heat-killed L. paracasei LP-33 10 billion cells daily for 30 days improves quality of life related to overall symptom severity or level of bother by 18% and 22%, respectively, when compared with placebo. Efficacy was not inferior to live L. paracasei LP-33 (107532).
Atopic dermatitis (eczema). Oral live Lacticaseibacillus paracasei, alone or in combination with other probiotics, seems to be beneficial for the treatment of atopic dermatitis in infants and children and for preventing atopic dermatitis when provided to the infant after exposure during pregnancy. It is unclear if heat-killed L. paracasei is beneficial for the treatment of atopic dermatitis. Details: In children aged 1-18 years, clinical research shows that taking L. paracasei 2 billion colony-forming units (CFUs) daily, alone or with Limosilactobacillus fermentum 2 billion colony-forming units (CFUs) daily each, for 3 months modestly reduces symptoms of atopic dermatitis when compared with placebo (98440). However, another clinical trial shows that administering formula containing lyophilized L. paracasei CNCM I-2116 to infants aged 3-6 months does not reduce atopic dermatitis severity or the prevalence of atopic dermatitis after 12 weeks of treatment (90256). Heat-killed L. paracasei has also been investigated in children with atopic dermatitis. Clinical research in infants ages 4-30 months shows that, in addition to topical fluticasone propionate cream, taking heat-treated L. paracasei GM-080 daily for 16 weeks does not further improve symptoms when compared with using the topical fluticasone propionate cream alone (102406). Other clinical research has investigated the effects of L. paracasei in combination with other probiotics for the PREVENTION of atopic dermatitis. A combination of L. paracasei, Ligilactobacillus salivarius, Bifidobacterium animalis subsp. lactis, and Bifidobacterium bifidum, a total of 10 billion CFUs daily provided from 36 weeks' gestation and then to the infant until age 6 months, reduces the prevalence of atopic dermatitis at age two by approximately 60% (90234). Similar findings occurred in clinical research investigating the effect of L. paracasei ST11 and B. longum BL999 (ST11+BL999) for the last 2 months of pregnancy and first 2 months of breastfeeding (90234,90285).
Common cold. A combination of Lacticaseibacillus paracasei and Lactiplantibacillus plantarum seems to be beneficial for reducing the incidence or severity of the common cold. The effects of L. paracasei alone are unclear. Details: Clinical research shows that taking L. plantarum HEAL 9 (DSM 15312) and L. paracasei 8700:2 (DSM 13434) (Probi Defendum, Probi AB) 1 billion colony-forming units (CFUs) daily for 12 weeks reduces the incidence of the common cold by about 12% and reduces the number of symptomatic days from 8.6 to 6.2 when compared with placebo (17119). Additional clinical research in adults at increased risk of a common cold shows that taking this same combination for 12 weeks does not reduce the incidence of developing a common cold when compared with placebo. However, symptom severity was modestly reduced. Also, each episode was reduced by an average of 1.1 days (107557). A more recent clinical study in adults at increased risk of developing a common cold shows that taking the same combination does not reduce symptom severity or the absolute number of common cold episodes when compared with placebo. However, in individuals with at least one cold, the mean number of colds was reduced by 0.12 over the 12-week period. In addition, there were modest overall reductions in the incidence of recurring colds and the use of analgesics (107555). A smaller clinical trial using the same product at the same dose and duration has also been conducted in children aged 1-6 years in daycare. The severity of nasal congestion/runny nose was modestly reduced when compared with placebo in this population. However, there were no differences between groups in the overall incidence, severity, or duration of common colds or upper respiratory tract infections or the number of days absent from daycare (107556). This latter trial was terminated prior to the completion of the planned patient recruitment for reasons unrelated to adverse effects, which may have impacted the findings.

Antibiotic-associated diarrhea. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in patients taking amoxicillin 500 mg twice daily for 7 days shows that taking a specific combination probiotic (Ecologic AAD) twice daily for 14 days modestly reduces the frequency of loose stools when compared with placebo. Of those taking probiotics, 48% reported a frequency of three or more stools daily and/or stools with a loose consistency over at least two days, compared with 79% of those taking placebo. The product provided L. paracasei NIZO 3672, Bifidobacterium bifidum NIZO 3804, Bifidobacterium animalis subsp. lactis NIZO 3680, Enterococcus faecium NIZO 3886, Lactobacillus acidophilus NIZO 3678 and NIZO 3887, Lactiplantibacillus plantarum NIZO 3684, Lacticaseibacillus rhamnosus NIZO 3689, and Ligilactobacillus salivarius NIZO 3675 as 1 billion colony-forming units each daily (95405).
Asthenopia (eye strain). It is unclear if oral heat-killed Lacticaseibacillus paracasei is beneficial for asthenopia. Details: Preliminary clinical research shows that taking heat-killed L. paracasei 50 mg daily for 8 weeks does not decrease eye fatigue induced by blue-light emitting devices when compared with placebo. However, a subgroup analysis shows that in patients who report eye fatigue at baseline, subjective symptoms of eye fatigue and eye redness are reduced after exposure to blue-light emitting devices (98429).
Asthma. It is unclear if oral Lacticaseibacillus paracasei is beneficial for asthma. Details: A small clinical study in children with asthma shows that taking L. paracasei GMNL-133 (LP) 2 billion colony-forming units (CFUs), Limosilactobacillus fermentum GM-090 (LF) 2 billion CFUs, or both strains together daily for 3 months seems to modestly reduce asthma severity and increase Childhood Asthma Control Test (C-ACT) scores when compared with placebo (99785).
Cancer. Although there has been interest in using oral Lacticaseibacillus paracasei for cancer prevention or treatment, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
Canker sores. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial shows that taking a combination of L. paracasei, Lacticaseibacillus rhamnosus, Lactobacillus acidophilus, and Bifidobacterium animalis subsp. lactis modestly reduces pain, but not the number of lesions or healing time, when compared with placebo (107548).
Clostridioides difficile infection. Although there has been interest in using oral Lacticaseibacillus paracasei for C. difficile infection prevention, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
Dental caries. It is unclear if oral Lacticaseibacillus paracasei is beneficial for dental caries prevention. Details: Preliminary clinical research shows that giving infants a weaning cereal containing L. paracasei F19 (Semper AB) from 4 months of age until 13 months of age does not reduce the risk of dental caries in the primary or permanent teeth by the age of 3, 6, or 9 years (90260).
Diabetes. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with gestational diabetes shows that taking a specific product containing L. paracasei and other probiotics (Visbiome, ExeGi Pharma) as a total of 112.5 billion colony-forming units (CFUs) twice daily for 8 weeks does not affect levels of fasting blood glucose or glycated hemoglobin (HbA1c) when compared with placebo. However, there were small improvements in insulin levels and insulin resistance (107549). This same combination probiotic has also been evaluated in children 2-12 years of age with new-onset type 1 diabetes. One clinical study shows that taking Visbiome as 112.5 billion CFUs daily for 3 months modestly decreases HbA1c and insulin requirements when compared with placebo. Also, about three times as many children achieved remission, defined as insulin requirements of less than 0.5 U/kg daily and HbA1c of less than 7%. However, C-peptide levels and the maintenance of residual pancreatic beta-cell function were not affected when compared with placebo (107497).
Diarrhea. It is unclear if oral Lacticaseibacillus paracasei is beneficial for the treatment of diarrhea. Details: While the European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388), both guidelines note that most evidence is low quality. Also, evidence related to the use of L. paracasei, specifically, is lacking.
HIV/AIDS. Although there has been interest in using oral Lacticaseibacillus paracasei for HIV/AIDS, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
Hypercholesterolemia. Although there has been interest in using oral Lacticaseibacillus paracasei for hypercholesterolemia, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
Irritable bowel syndrome (IBS). It is unclear if oral Lacticaseibacillus paracasei is beneficial for IBS. Details: One clinical study shows that taking a specific multi-species probiotic (Visbiome, ExeGi Pharma) containing L. paracasei and seven other probiotics as 450 billion colony-forming units (CFUs) daily in two divided doses for 8 weeks improves abdominal bloating, but not abdominal pain, flatulence, or number of stools, in patients with diarrhea-predominant IBS (IBS-D) (11379). However, adding this product as 900 billion CFUs daily to a sham diet or a low-FODMAP diet for 4 weeks does not improve IBS symptoms when compared with placebo (98741). Another clinical study in patients with IBS-D shows that taking a specific multi-species probiotic (NordBiotic, MBM Biotix) containing L. paracasei LPC100, Lacticaseibacillus rhamnosus LR110, Lactobacillus acidophilus LA120, Lacticaseibacillus casei LC130, and Lactiplantibacillus plantarum LP140, Bifidobacterium breve BB010, Bifidobacterium longum BL020, Bifidobacterium bifidum BF030, Bifidobacterium animalis subsp. lactis BL040, and Streptococcus thermophilus ST250 as 2.5 billion CFUs total twice daily for 8 weeks improves overall symptom severity, as well as pain severity, pain frequency, and quality of life when compared with placebo. Symptom severity was rated as mild by approximately 60% of those taking the probiotic mixture, compared with 30% of those taking placebo (107516). However, other clinical research shows that taking L. paracasei HA-196 10 billion CFUs daily for 8 weeks or a combination of L. paracasei, L. acidophilus, and B. animalis subsp. lactis BB-12 (Cultura) 13-20 billion CFUs daily for 6 months does not improve symptoms of IBS (90236,94696,94697,103440).
Lyme disease. Although there has been interest in using oral Lacticaseibacillus paracasei for Lyme disease, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
Necrotizing enterocolitis (NEC). It is unclear if oral Lacticaseibacillus paracasei is beneficial for NEC. Details: Most meta-analyses of clinical research show that giving lactobacilli enterally reduces the risk of NEC and/or severe NEC in preterm, mainly very low birth weight (VLBW), infants. Some meta-analyses support the use of lactobacilli in combination with bifidobacteria, as opposed to lactobacilli alone for reducing the risk of NEC. However, the effects of L. paracasei, specifically, are unclear (95344,95351,103437,103445,104157,105162,105164).
Pouchitis. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that continuous oral treatment for one year with a specific combination product (Visbiome, ExeGi Pharma) containing L. paracasei and other probiotics, 6 grams (300-500 billion live bacteria per gram) daily, for up to 12 months seems to maintain remission in 85% of patients with pouchitis (6087,12769).
Pregnancy-induced nausea and vomiting. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial shows that taking probiotics during pregnancy reduces the severity and duration of nausea and vomiting by 16% to 54%. There was also a small benefit on stool hardness. A specific probiotic (Probiotics 10, Nature's Bounty) was taken as 2 capsules daily for two back-to-back cycles of six days with probiotics and two days without. Each capsule contained a total of 10 billion colony-forming units (CFUs) of L. paracasei DSM 13434 and Lpc-37, Lactiplantibacillus plantarum 299v and DSM 15312, Lactobacillus delbrueckii subsp. bulgaricus Lb-87, Ligilactobacillus salivarius Ls-33, Levilactobacillus brevis Lbr-35, Lactobacillus acidophilus La-14, Lacticaseibacillus casei Lc-11, and Bifidobacterium animalis subsp. lactis Bl-04, along with inulin 200 mg (107199).
Prostatitis. It is unclear if oral Lacticaseibacillus paracasei is beneficial for prostatitis. Details: Preliminary clinical research in adults with chronic bacterial prostatitis who are receiving antibiotic treatment shows that taking L. paracasei CNCM I-1572 (L. casei DG) one capsule twice daily for 6 months improves clinical symptoms over baseline in 73% of patients and also reduces symptomatic recurrence and antibiotic use (105133). The validity of these findings is limited by the lack of a comparator group.
Rotaviral diarrhea. It is unclear if oral Lacticaseibacillus paracasei is beneficial for rotaviral diarrhea. Details: The current guidelines related to the treatment of viral diarrhea are conflicting. While the World Gastroenterology Organization has not made a recommendation (98471), the European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388). However, these guidelines note that most evidence is low quality and is not specific to rotavirus infection. Furthermore, these guidelines were released prior to the publication of the most recent, high-quality studies showing no benefit with the use of certain probiotics (98427,98428). Also, research on the use of L. paracasei, specifically, is lacking.
Short bowel syndrome. Although there has been interest in using oral Lacticaseibacillus paracasei for short bowel syndrome, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
Ulcerative colitis. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: The best evidence of benefit is for a specific combination product (Visbiome, ExeGi Pharma). Doses of 3 grams (equivalent to 900 billion colony-forming units (CFUs)) once or twice daily have been used in combination with conventional treatment. In children aged 1-16 years, doses of 450-1800 billion CFUs for up to one year have been used (3261,14370,14371,16841,95337). A meta-analysis of clinical research shows that taking this product as an adjunct to standard ulcerative colitis treatment can increase remissions rates in adults and children by about 1.7-fold when compared with standard treatment alone (95337). There is also evidence that it is beneficial for improving remission rates in patients who do not adequately respond to conventional treatment (14371). More evidence is needed to rate Lacticaseibacillus paracasei for these uses.

LACTIPLANTIBACILLUS PLANTARUM (Lactobacillus plantarum)

Atopic dermatitis (eczema). Oral Lactiplantibacillus plantarum seems to be beneficial for the treatment of atopic dermatitis. Details: Clinical research in children aged 1-13 years shows that taking L. plantarum CJLP133 50 billion colony-forming units (CFUs) twice daily for 12 weeks modestly reduces overall symptom severity when compared with placebo. However, there was no effect on the use of topical corticosteroids (90259). In adults, clinical research shows that taking 1 billion CFUs each of L. plantarum PBS067, Limilactobacillus reuteri PBS072, and Lacticaseibacillus rhamnosus LRH020 daily for 56 days modestly reduces the severity of symptoms and improves skin smoothness and moisturization for up to an additional 28 days when compared with placebo (107506).
Common cold. A combination of Lactiplantibacillus plantarum and Lacticaseibacillus paracasei seems to be beneficial for reducing the incidence or severity of the common cold. The effects of L. plantarum alone are unclear. Details: Clinical research shows that taking L. plantarum HEAL 9 (DSM 15312) and L. paracasei 8700:2 (DSM 13434) (Probi Defendum, Probi AB) 1 billion colony-forming units (CFUs) daily for 12 weeks reduces the incidence of the common cold by about 12% and reduces the number of symptomatic days from 8.6 to 6.2 when compared with placebo (17119). Additional clinical research in adults who are at an increased risk for the common cold shows that taking this same combination for 12 weeks does not reduce the incidence of developing a cold when compared with placebo. However, symptom severity was modestly reduced. Also, each episode was reduced by an average of 1.1 days (107557). A more recent clinical study in a similar population shows that taking the same combination does not reduce symptom severity or the absolute number of common cold episodes when compared with placebo. However, in individuals with at least one cold, the mean number of colds was reduced by 0.12 over the 12-week period. In addition, there were modest overall reductions in the incidence of recurring colds and the use of analgesics (107555). A smaller clinical trial using the same product at the same dose and duration has also been conducted in children aged 1-6 years in daycare. The severity of nasal congestion/runny nose was modestly reduced when compared with placebo in this population. However, there were no differences between groups in the overall incidence, severity, or duration of common colds or upper respiratory tract infections or the number of days absent from daycare (107556). This latter trial was terminated prior to the completion of the planned patient recruitment for reasons unrelated to adverse effects, which may have impacted the findings.
Hypercholesterolemia. Oral Lactiplantibacillus plantarum seems to be modestly beneficial for lowering cholesterol levels. Details: Meta-analyses of a small number of clinical trials shows that taking L. plantarum can reduce total cholesterol and low-density lipoprotein (LDL) cholesterol in patients with or without hypercholesterolemia. In one publication these reductions were by about 14 mg/dL and 11 mg/dL, respectively (95399,107591). One of the studies included in the analyses utilized a mixture of three strains of L. plantarum (CECT 7527, 7528, and 7529, AB-LIFEe), containing a total daily dose of 1.2 billion colony-forming units (CFUs) daily for 12 weeks (90255). However, a more recent study shows that taking L. plantarum ECGC 13110402 as 2 billion CFUs twice daily for 12 weeks does not affect total or LDL cholesterol levels when compared with placebo (107559). Taking L. plantarum does not appear to improve high-density lipoprotein (HDL) cholesterol or triglyceride levels in most studies (90255,95399). However, one study shows that taking L. plantarum ECGC 13110402 as 2 billion CFUs twice daily for 12 weeks modestly increases levels of HDL cholesterol, with no effect on triglyceride levels, when compared with placebo (107559).
Irritable bowel syndrome (IBS). Some research shows that Lactiplantibacillus plantarum, alone or as part of specific combination products, may be beneficial for IBS. Details: Three clinical studies show that taking L. plantarum 299v as a beverage (ProViva) containing 50 million colony-forming units (CFUs) or as capsules containing 10 billion CFUs daily for 4 weeks improves abdominal pain and flatulence when compared with placebo in IBS patients (10419,16746,90249). In addition, a meta-analysis of clinical research in patients with IBS shows that taking L. plantarum increases the frequency of abdominal pain relief and the frequency of global responders (107594). However, another preliminary clinical trial using L. plantarum 299v found no benefit (12770). Some clinical research has also shown that specific combination probiotics may be beneficial. One clinical study shows that taking a specific multi-species probiotic (Visbiome, ExeGi Pharma) containing L. plantarum and seven other probiotics as 450 billion CFUs daily in two divided doses for 8 weeks improves abdominal bloating, but not abdominal pain, flatulence, or number of stools, in patients with diarrhea-predominant IBS (IBS-D) (11379). Another clinical study in patients with IBS-D shows that taking a specific multi-species probiotic (NordBiotic, MBM Biotix) containing L. plantarum LP140, Lacticaseibacillus rhamnosus LR110, Lacticaseibacillus paracasei LPC100, Lactobacillus acidophilus LA120, Lacticaseibacillus casei LC130, Bifidobacterium breve BB010, Bifidobacterium longum BL020, Bifidobacterium bifidum BF030, Bifidobacterium animalis subsp. lactis BL040, and Streptococcus thermophilus ST250 2.5 billion CFUs daily twice daily for 8 weeks improves overall symptom severity, as well as pain severity, pain frequency, and quality of life, when compared with placebo. Symptom severity was rated as mild by approximately 60% of those taking the probiotic mixture, compared with 30% of those taking placebo (107516).
Respiratory tract infections. Oral Lactiplantibacillus plantarum seems to prevent respiratory tract infections. Details: Clinical research in healthy adults shows that taking L. plantarum DR7 (GN Pharmaceuticals Sdn. Bhd.) 1 billion CFUs daily for 12 weeks reduces the duration of nasal symptoms by about 5 days when compared with placebo. There was also a modest decrease in the frequency of upper respiratory tract infections (URTIs) (102290). Also, in overweight adults or adults with obesity, taking 50 billion CFUs of a specific combination of L. plantarum, Lactobacillus acidophilus, Bifidobacterium bifidum, and Bifidobacterium animalis subsp. lactis (Lab4P) for 24 weeks reduces the overall likelihood of having URTI symptoms, such as sneeze, cough, and blocked nose, by approximately 40% when compared with placebo (103439).
Ulcerative colitis. Oral Lactiplantibacillus plantarum, alone or in combination with other probiotics, seems to improve remission rates and prevent symptom relapse when used in combination with standard therapy. Details: The best evidence of benefit is for a specific multi-species probiotic (Visbiome, ExeGi Pharma). Doses of 3 grams (equivalent to 900 billion colony-forming units (CFUs)) once or twice daily have been used in combination with conventional treatment. In children aged 1-16 years, doses of 450-1800 billion CFUs for up to one year have been used (3261,14370,14371,16841,95337). A meta-analysis of clinical research shows that taking this product as an adjunct to standard ulcerative colitis treatment can increase remission rates in adults and children by about 1.7-fold when compared with standard treatment alone (95337). Most research also shows that taking this product prevents relapse in people who are already in remission (3261,16841,95337). Other preliminary clinical research shows that taking 250 mL of a different product containing L. plantarum 299v (Profermin) 100 million CFUs/mL twice daily for 8 weeks reduces the severity of flare-up symptoms and increases the rate of remission by about 2-fold when compared with treatment with a specific nutritional beverage (Fresubin Original, Fresenius Kabi) (90271).

Antibiotic-associated diarrhea. Lactiplantibacillus plantarum, alone or in combination with other probiotics, does not seem to reduce the risk of antibiotic-associated diarrhea (AAD) in adults and children. However, it might reduce the risk of loose stools. Details: Clinical research in children aged 1-11 years shows that taking L. plantarum 299v (ProViva) 10 billion colony-forming units (CFUs) daily during antibiotic treatment and for an additional week does not reduce general abdominal symptoms, the overall incidence of loose or watery stools, or the incidence of AAD (defined as at least three loose or watery stools within a 24 hour period) when compared with placebo (95395). Also, a small clinical trial in adults shows that taking L. plantarum 10 billion CFUs daily does not reduce the incidence of AAD when compared with placebo. However, there was a modest reduction in the incidence of having at least one loose or watery stool during the antibiotic treatment period. Although the risk of nausea was reduced, there was no effect of L. plantarum on vomiting or abdominal pain. In this study, L. plantarum was provided in a drink (200 mL) containing blueberries and oat gruel which was started within 48 hours of the initiation of antibiotics and continued for a week after completion (107552). Combination products have also been investigated. In a small clinical trial in children aged 5 months to 16 years, taking a combination of L. plantarum PL02, Bifidobacterium longum PL03, and Lacticaseibacillus rhamnosus KL53A twice daily during antibiotic treatment does not reduce the rate of AAD when compared with placebo. However, there was a modest reduction in the number of stools each day (107553). The total number of cases of AAD was extremely low in this study, making it difficult to draw conclusions. In contrast, clinical research in adults shows that taking a total of 5 billion CFUs twice daily for 14 days of a specific product (Ecologic AAD) providing L. plantarum NIZO 3684, Bifidobacterium bifidum NIZO 3804, Bifidobacterium animalis subsp. lactis NIZO 3680, Enterococcus faecium NIZO 3886, Lactobacillus acidophilus NIZO 3678 and NIZO 3887, Lacticaseibacillus paracasei NIZO 3672, Lacticaseibacillus rhamnosus NIZO 3689, and Ligilactobacillus salivarius NIZO 3675 modestly reduces the risk of having at least three bowel movements daily and/or having stools with a loose consistency for at least two days during antibiotic treatment (95405). However, it is unclear whether this benefit was related to L. plantarum or another probiotic.

LACTOBACILLUS ACIDOPHILUS (Lactobacillus salivarius, Lactobacillus rhamnosus, Lactobacillus bulgaricus)

Acne. It is unclear if oral Lactiplantibacillus plantarum is beneficial for acne. Details: A small clinical trial shows that taking L. plantarum CJLP55 (KCTC 11401BP) 10 billion colony-forming units daily for 12 weeks modestly reduces the total and inflammatory lesion count, as well as acne severity, when compared with placebo. There were also modest improvements in skin sebum levels and hydration (107511).
Aging skin. It is unclear if oral Lactiplantibacillus plantarum is beneficial for aging skin. Details: A small clinical study in healthy, middle-aged and older adults shows that taking L. plantarum HY7714 10 billion colony-forming units daily improves skin hydration and reduces wrinkle depth when compared with placebo (102294).
Autism spectrum disorder. It is unclear if oral Lactiplantibacillus plantarum is beneficial for autism spectrum disorder. Details: A small clinical trial in males aged 7-15 years with autism spectrum disorder shows that taking L. plantarum PS128 daily for 4 weeks does not improve behavior or social response when compared with placebo. However, the probiotic modestly reduced specific behaviors, including opposition and defiance, in a subgroup of children aged 7-12 years (107540).
Bacterial vaginosis. Oral Lactiplantibacillus plantarum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A combination product containing L. plantarum has been tried in patients with both bacterial vaginosis and aerobic vaginitis, which typically occurs after unsuccessful treatment of bacterial vaginosis with antibiotics. A clinical study in these patients shows that taking a specific combination product (prOVag, IBSS BIOMED S.A.) containing a total of 100 million colony-forming units of L. plantarum 57B, Limosilactobacillus fermentum 57A, and Lactobacillus gasseri 57C daily for 10 days in conjunction with standard metronidazole treatment increases the duration of symptom-free remission to 71 days, compared with 47 days in those taking metronidazole alone (99784).
Cancer. Although there has been interest in using oral Lactiplantibacillus plantarum for cancer prevention or treatment, there is insufficient reliable information about the clinical effects of L. plantarum for this condition.
Clostridioides difficile infection. It is unclear if oral Lactiplantibacillus plantarum is beneficial for C. difficile prevention. Details: A small clinical trial in hospitalized patients shows that taking L. plantarum 299v as part of a fermented oatmeal gruel, as 80 billion colony-forming units (CFUs) twice daily for three days and 40 billion CFUs twice daily until ICU departure, reduces the likelihood of C. difficile colonization. C. difficile was detected in the feces of 19% of patients taking placebo, compared with 0% of the patients taking L. plantarum (107554). Some research shows that taking L. plantarum 299v might be effective for preventing C. difficile diarrhea recurrence (11378). Current guidelines from the Infectious Diseases Society of America (IDSA) state that there is insufficient information to recommend administration of probiotics for the primary prevention of C. difficile-associated diarrhea (107538).
Constipation. Oral Lactiplantibacillus plantarum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Some combinations products containing L. plantarum have been shown to increase stool frequency and improve symptoms of functional constipation in adults. These include L. plantarum LMG P-21021 and Bifidobacterium breve DSM 16604 5 billion CFUs daily for 30 days (95342) and a combination of L. plantarum IDCC 3501, Lacticaseibacillus casei IDCC 3451, Lacticaseibacillus rhamnosus IDCC 3201, Bifidobacterium lactis IDCC 4301, Bifidobacterium breve IDCC 4401, Lactococcus lactis IDCC 2301, xylooligosaccharide, and dietary fiber as nondigestible maltodextrin, oat fiber, and psyllium husk fiber (ID-HWS1000) (107517).
Coronavirus disease 2019 (COVID-19). Oral Lactiplantibacillus plantarum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In symptomatic COVID-19 outpatients, clinical research shows that taking a total of 2 billion colony-forming units (CFUs) of a specific combination of L. plantarum KABP022, KABP023, and KAPB033 and Pediococcus acidilactici KABP021 (AB21) daily for 30 days increases the rate of complete remission after 30 days by approximately 89% when compared with placebo. There was also a modest reduction in days with specific symptoms, including fever, cough, headache, and some gastrointestinal symptoms (107526).
Critical illness (trauma). It is unclear if oral Lactiplantibacillus plantarum is beneficial for critical illness. Details: Clinical research in patients in intensive care shows that taking L. plantarum 299v 20 billion colony-forming units (CFUs) daily for 60 days does not affect the number of days alive, the rate of nosocomial infections, or the number of patients discharged by day 60 when compared with placebo (105136). However, a meta-analysis of four clinical trials in critically ill patients on antibiotics shows that taking L. plantarum alone or with other probiotics reduces the risk of infections by 30% when compared with not taking L. plantarum (105143). Also, other clinical research shows that taking L. plantarum 500 million CFUs, Lactobacillus acidophilus LA-5 1.75 billion CFUs, Bifidobacterium lactis BB12 1.75 billion CFUs, and Saccharomyces boulardii 1.5 billion CFUs twice daily for 15 days modestly reduces the risk of sepsis, as well as the length of stay in the ICU and hospital, when compared with placebo (107524).
Depression. Although there has been interest in using oral Lactiplantibacillus plantarum for depression, there is insufficient reliable information about the clinical effects of L. plantarum for this condition.
Diabetes. Oral Lactiplantibacillus plantarum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with gestational diabetes shows that taking a specific product containing L. plantarum and seven other probiotics (Visbiome, ExeGi Pharma) as a total of 112.5 billion colony-forming units (CFUs) twice daily for 8 weeks does not affect levels of fasting blood glucose or glycated hemoglobin (HbA1c) when compared with placebo. However, there were small improvements in insulin levels and insulin resistance (107549). In children aged 2-12 years with new-onset type 1 diabetes, taking this same combination product as 112.5 billion CFUs daily for 3 months modestly decreases HbA1c and insulin requirements when compared with placebo. Also, about three times as many children achieved remission, defined as insulin requirements of less than 0.5 U/kg daily and HbA1c less than 7%. C-peptide levels and the maintenance of residual pancreatic beta-cell function were not changed when compared with placebo in either study (107497).
Diarrhea. It is unclear if oral Lactiplantibacillus plantarum is beneficial for acute or chronic diarrhea. Details: A small clinical trial in patients with unspecified chronic diarrhea shows that taking L. plantarum CCFM1143 3.52 billion colony-forming units daily for 30 days modestly reduces stool frequency when compared with baseline. However, it is unclear if it is more beneficial than placebo. There was no effect on abdominal symptoms or quality of life (107500). While the European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388), both guidelines note that most evidence is low quality, and this recommendation is not specific to L. plantarum.
HIV/AIDS. Although there has been interest in using oral Lactiplantibacillus plantarum for HIV/AIDS, there is insufficient reliable information about the clinical effects of L. plantarum for this condition.
Hypertension. It is unclear if oral Lactiplantibacillus plantarum is beneficial for hypertension. Details: A meta-analysis of clinical research shows that taking L. plantarum reduces systolic and diastolic blood pressure by 1.6 mmHg and 1 mmHg, respectively, when compared with placebo in various populations. Studies in the analyses included L. plantarum alone or with other probiotics, in doses ranging from 1 billion colony-forming units (CFUs) daily to 1.5 trillion CFUs daily for 2-12 weeks (107558). However, the effects of L. plantarum in patients with diagnosed hypertension are unclear.
Hypertriglyceridemia. It is unclear if oral Lactiplantibacillus plantarum is beneficial for hypertriglyceridemia. Details: A clinical trial in patients with hypertriglyceridemia shows that taking 2 grams of a powdered supplement containing L. plantarum KY1032 and Latilactobacillus curvatus HY7601 50 billion colony-forming units daily for 12 weeks reduces triglycerides by 18%, compared with a 0% reduction in patients taking placebo (102289).
Impaired glucose tolerance (prediabetes). It is unclear if oral Lactiplantibacillus plantarum is beneficial for prediabetes. Details: A small clinical trial shows that taking L. plantarum HAC01 as 4 billon colony-forming units (CFUs) daily for 8 weeks modestly reduces glycated hemoglobin (HbA1c) when compared with placebo. There was also a difference in 2-hour postprandial glucose levels; however, this difference seems to be related to an increased level in the placebo group. Also, there was no effect on fasting blood glucose or insulin levels, measures of insulin resistance, or plasma lipid levels (107512). The clinical significance of the change in HbA1c is unclear since the supplementation period was only 8 weeks.
Insomnia. It is unclear if oral Lactiplantibacillus plantarum is beneficial for insomnia. Details: A small clinical trial in patients with self-reported insomnia shows that taking L. plantarum PS128 (Bened Biomedical Co. Ltd.) 60 billion colony-forming units (CFUs) each evening for 30 days does not improve overall sleep quality or insomnia severity when compared with placebo. However, there were some improvements in feelings of depression and fatigue, as well as a reduction in awakening during deep sleep, when compared with placebo (107508).
Iron deficiency anemia. Although there has been interest in using oral Lactiplantibacillus plantarum for iron deficiency anemia, there is insufficient reliable information about the clinical effects of L. plantarum for this condition.
Lyme disease. Although there has been interest in using oral Lactiplantibacillus plantarum for Lyme disease, there is insufficient reliable information about the clinical effects of L. plantarum for this condition.
Metabolic syndrome. Oral Lactiplantibacillus plantarum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in elderly patients with metabolic syndrome shows that taking a combination of L. plantarum PBS067-DSM 24,937, Lactobacillus acidophilus PBS066-DSM 24,936, and Limisilactobacillus reuteri PBS072-DSM 25,175 as 2 billion colony-forming units (CFUs) each, along with the prebiotics inulin and fructo-oligosaccharides, daily for 60 days reduces the number of patients diagnosed with metabolic syndrome by 23%, compared with a 10% reduction in those taking placebo. In the probiotic group, there were modest improvements in waist circumference and levels of fasting plasma insulin, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and inflammatory mediators when compared with placebo. However, there were no significant differences in fasting blood glucose or blood pressure. All patients in this study were on a Mediterranean-like standard diet (107560).
Necrotizing enterocolitis (NEC). It is unclear if oral Lactiplantibacillus plantarum is beneficial for NEC. Details: Most meta-analyses of clinical research show that giving lactobacilli enterally reduces the risk of NEC and/or severe NEC in preterm, mainly very low birth weight (VLBW), infants. Some meta-analyses support the use of lactobacilli in combination with bifidobacteria, as opposed to lactobacilli alone for reducing the risk of NEC. However, the effects of L. plantarum, specifically, are unclear (95344,95351,103437,103445,104157,105162,105164).
Obesity. It is unclear if oral live or heat-killed Lactiplantibacillus plantarum are beneficial for weight loss. Details: Clinical research in adults with overweight or obesity shows that taking 50 billion colony-forming units (CFUs) of a specific combination of L. plantarum, Lactobacillus acidophilus, Bifidobacterium bifidum, and Bifidobacterium animalis subsp. lactis (Lab4P) for 24 weeks reduces body weight by an additional 1.3 kg more than placebo (103439). Other clinical research in overweight adults shows that taking heat-killed L. plantarum L-137 (HK L-137) for 12 weeks does not reduce body mass index (BMI) when compared with placebo. However, levels of aspartate aminotransferase and alanine aminotransferase were reduced. Taking L. plantarum also seems to suppress the increase in total and low-density lipoprotein (LDL) cholesterol levels seen in those taking placebo (107534).
Osteoporosis. Although there has been interest in using oral Lactiplantibacillus plantarum for osteoporosis, there is insufficient reliable information about the clinical effects of L. plantarum for this condition.
Parkinson disease. It is unclear if oral Lactiplantibacillus plantarum is beneficial for Parkinson disease. Details: A small preliminary clinical trial in patients with Parkinson disease on standard treatment shows that taking L. plantarum PS128 60 billion colony-forming units each night for 12 weeks modestly improves motor function when compared with baseline. There was no improvement in non-motor symptoms including tremor and rigidity (107515).
Postoperative infection. Although there has been interest in using oral Lactiplantibacillus plantarum for preventing postoperative infection, there is insufficient reliable information about the clinical effects of L. plantarum for this condition.
Pouchitis. Oral Lactiplantibacillus plantarum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Continuous oral treatment for one year with a specific combination product (Visbiome, ExeGi Pharma) containing L. plantarum and other probiotics, as 6 grams (300-500 billion live bacteria per gram) daily for up to one year, seems to maintain remission of pouchitis in 85% of patients (6087,12769).
Pregnancy-induced nausea and vomiting. Oral Lactiplantibacillus plantarum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial shows that taking probiotics during pregnancy reduces the severity and duration of nausea and vomiting by 16% to 54%. There was also a small benefit on stool hardness. A specific probiotic (Probiotics 10, Nature's Bounty) was taken as 2 capsules daily for two back-to-back cycles of six days with probiotics and two days without. Each capsule contained a total of 10 billion colony-forming units (CFUs) of L. plantarum 299v and DSM 15312, Lactobacillus delbrueckii subsp. bulgaricus Lb-87, Lacticaseibacillus paracasei DSM 13434 and Lpc-37, Ligilactobacillus salivarius Ls-33, Levilactobacillus brevis Lbr-35, Lactobacillus acidophilus La-14, Lacticaseibacillus casei Lc-11, and Bifidobacterium lactis Bl-04, along with inulin 200 mg (107199).
Rheumatoid arthritis (RA). Although there has been interest in using oral Lactiplantibacillus plantarum for RA, there is insufficient reliable information about the clinical effects of L. plantarum for this condition.
Rotaviral diarrhea. It is unclear if oral Lactiplantibacillus plantarum is beneficial for rotaviral diarrhea. Details: The current guidelines related to the treatment of viral diarrhea are conflicting. While the World Gastroenterology Organization has not made a recommendation (98471), the European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388). However, these guidelines note that most evidence is low quality and is not specific to rotavirus infection. Furthermore, these guidelines were released prior to the publication of the most recent, high-quality studies showing no benefit with the use of specific probiotics (98427,98428). Research on the use of L. plantarum, specifically, is lacking.
Short bowel syndrome. Although there has been interest in using oral Lactiplantibacillus plantarum for short bowel syndrome, there is insufficient reliable information about the clinical effects of L. plantarum for this condition.
Tourette syndrome. It is unclear if oral Lactiplantibacillus plantarum is beneficial for Tourette syndrome. Details: A small clinical trial in children aged 5-18 years with Tourette syndrome shows that taking L. plantarum PS128 DSM 28632 (Bened Biomedical Co., Ltd.) 30 billion colony-forming units (CFUs) twice daily for two months does not reduce the severity of tics or other symptoms of Tourette syndrome when compared with placebo (107501). This study may have been underpowered to detect a difference between groups for many endpoints.
Urinary tract infections (UTIs). It is unclear if intravaginal Lactiplantibacillus plantarum is beneficial for the prevention of UTIs. Details: One large, non-randomized, clinical study in otherwise healthy patients with recurrent bacterial vaginosis shows that intravaginal use of L. plantarum P 17630 daily for 6 days, then weekly for 16 weeks, does not reduce the risk of recurrent UTI when compared with control (98435).
Ventilator-associated pneumonia (VAP). Oral Lactiplantibacillus plantarum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that taking L. plantarum 500 million colony-forming units (CFUs), Lactobacillus acidophilus LA-5 1.75 billion CFUs, Bifidobacterium lactis BB12 1.75 billion CFUs, and Saccharomyces boulardii 1.5 billion CFUs twice daily for 15 days reduces the rate of VAP to 12%, compared with 28% in patients taking placebo. Half of the dose was given onto the oropharynx and half via a nasogastric tube (107524). More evidence is needed to rate Lactiplantibacillus plantarum for these uses.

Antibiotic-associated diarrhea. Most research shows that oral Lactobacillus acidophilus, alone or in combination with other probiotics, seems to reduce the risk of antibiotic-associated diarrhea (AAD) in adults. Details: A small clinical trial in elderly adults shows that taking L. acidophilus reduces the risk of AAD. AAD occurred in 17% of those taking L. acidophilus (Florajen Acidophilus) 20 billion colony-forming units (CFUs) three times daily, compared with 37% of those taking placebo (95400). A number of combination products have also demonstrated benefit for preventing AAD, including Bio-K+ Cl1285 which provides L. acidophilus CL1285, Lacticaseibacillus casei LBC80R, and Lacticaseibacillus rhamnosus CLR2 as 100 billion CFUs daily (25494,95402,95403); L. acidophilus and Bifidobacterium animalis subsp. lactis (90239); and Ecologic AAD which provides L. acidophilus NIZO 3678 and NIZO 3887, Lacticaseibacillus paracasei NIZO 3672, Lactiplantibacillus plantarum NIZO 3684, L. rhamnosus NIZO 3689, Ligilactobacillus salivarius NIZO 3675, Bifidobacterium bifidum NIZO 3804, Bifidobacterium animalis subsp. lactis NIZO 3680, and Enterococcus faecium NIZO 3886 (95405). However, some combination products have not demonstrated benefit. Clinical research shows that taking a combination of L. acidophilus and bifidobacteria or a combination of L. acidophilus and Lactobacillus delbrueckii subsp. bulgaricus (Lactinex) is not beneficial (90231,90239,92255,95385).
Bacterial vaginosis. Most clinical research shows that intravaginal application of Lactobacillus acidophilus may be helpful for the treatment of bacterial vaginosis. It is unclear if oral L. acidophilus is beneficial for the treatment or prevention of bacterial vaginosis. Details: One clinical trial shows that intravaginal suppositories containing 100 million to 1 billion colony-forming units (CFUs) of L. acidophilus (Vivag, Pharma Vinci A/S) given twice daily for 6 days improve bacterial vaginosis resolution rates when compared with placebo (13177). Another clinical trial shows that using 1-2 vaginal tablets containing viable L. acidophilus 10 million CFUs and estriol 0.03 mg per tablet (Gynoflor, Medinova) daily for 6 days increases cure rates when compared with placebo (13176). However, using this product in combination with metronidazole 400 mg twice daily for 7 days does not improve outcomes when compared with metronidazole alone (90237). Oral L. acidophilus has also been evaluated. Preliminary clinical research shows that eating yogurt 125 mL daily enriched with L. acidophilus for 2 months might slightly decrease the incidence of recurrent bacterial vaginosis (1245).
Helicobacter pylori. Oral Lactobacillus acidophilus, usually in combination with other probiotics, seems to improve H. pylori eradication when used along with standard therapies. It is unclear if heat-killed L. acidophilus is beneficial for H. pylori eradication. Details: A meta-analysis of clinical studies utilizing probiotic products containing L. acidophilus shows that these products can improve H. pylori eradication rates 1.14- to 1.24-fold when taken in combination with triple therapy consisting of a proton-pump inhibitor (PPI), clarithromycin, and amoxicillin. Based on these results, about 7-11 patients would need to be treated in order for one additional patient to achieve complete remission (95394). Only one of the trials in this analysis investigated L. acidophilus alone; an additional 8 used L. acidophilus in combination with other probiotics. Individual clinical trials have shown that a combination of L. acidophilus, Enterococcus faecalis, and Bacillus subtilis 30 million colony-forming units (CFUs) total, taken in three divided doses daily, from 2 weeks prior tol 2 weeks after triple therapy increases H. pylori eradication when compared with triple therapy alone (90248). In children, a combination of L. acidophilus (strain 5) 9.4 billion CFUs and Bifidobacterium bifidum (strain 12) 8.6 billion CFUs in combination with a PPI, clarithromycin, and amoxicillin or metronidazole has been used daily for 2 weeks, followed by the probiotics alone for an additional 4 weeks (90602). However, other individual clinical trials have shown that L. acidophilus in combination with Lacticaseibacillus rhamnosus, Bifidobacterium bifidum, and Streptococcus faecium may not improve eradication rates when taken with triple therapy consisting of furazolidone, tetracycline, and lansoprazole (90279). Also, taking L. acidophilus along with six other probiotics in conjunction with bismuth quadruple therapy does not seem to improve H. pylori eradication rates when compared with placebo and bismuth quadruple therapy (90291). Also, taking L. acidophilus and L. casei without any standard H. pylori therapy does not improve H. pylori eradication rates in adults (12766). Heat-killed L. acidophilus has also been investigated in adults with H. pylori. Taking a lyophilized and inactivated culture of L. acidophilus (Lacteol Fort) containing 5 billion cells, 3 times daily for 10 days, modestly increases the eradication rate in patients using triple therapy of rabeprazole, clarithromycin, and amoxicillin for 7 days (8562).
Irritable bowel syndrome (IBS). Some research shows that oral live Lactobacillus acidophilus, taken alone or in combination with other probiotics, may be beneficial for IBS. The effects of non-viable, heat-killed L. acidophilus are unclear. Details: Clinical research in adults with IBS shows that taking L. acidophilus DDS-1 10 billion colony-forming units (CFUs) daily for 6 weeks modestly reduces the severity of abdominal pain when compared with placebo. Also, 52% of patients experienced a more than 30% reduction in pain severity, compared with 16% of those taking placebo. There were also improvements in abdominal distention and duration of pain; however, there were no changes in bowel habits (107581). L. acidophilus has also been examined in combination with other probiotics. One clinical study shows that taking a specific combination product (Visbiome, ExeGi Pharma) containing L. acidophilus and 7 other species as 450 billion CFUs daily in two divided doses for 8 weeks improves abdominal bloating, but not abdominal pain, flatulence, or number of stools, in patients with diarrhea-predominant IBS (IBS-D) (11379). Another clinical study in patients with IBS-D shows that taking a specific multi-species probiotic (NordBiotic, MBM Biotix) containing L. acidophilus LA120, Lacticaseibacillus rhamnosus LR110, Lacticaseibacillus paracasei LPC100, Lacticaseibacillus casei LC130, Lactiplantibacillus plantarum LP140, Bifidobacterium breve BB010, Bifidobacterium longum BL020, Bifidobacterium bifidum BF030, Bifidobacterium animalis subsp. lactis BL040, and Streptococcus thermophilus ST250 as 2.5 billion CFUs total twice daily for 8 weeks improves overall symptom severity, as well as pain severity, pain frequency, and quality of life, when compared with placebo. Symptom severity was rated as mild by approximately 60% of those taking the probiotic mixture, compared with 30% of those taking placebo (107516). However, other probiotic compounds containing L. acidophilus have not demonstrated benefit in most patients with IBS. These include L. acidophilus NCFM 10 billion CFUs daily for 12 weeks; L. acidophilus, L. paracasei, and Bifidobacterium animalis subsp. lactis BB-12 (Cultura) 13-20 billion CFUs daily for 6 months; or L. acidophilus CL1285, L. casei LBC80R, and L. rhamnosus CLR2 50 billion CFUs each daily for 3 months (90236,94696,94697,95365,99789). Further research is needed to determine which IBS subtype, if any, is most likely to benefit. Heat-killed L. acidophilus has also been investigated in patients with IBS. One clinical study shows that taking capsules containing heat-killed L. acidophilus (Lacteol Fort) 20 billion colony-forming units (CFUs) daily for 6 weeks improves abdominal pain, bloating, and number and quality of stools when compared with placebo (7744). Also, in patients with IBS-D, observational research has found that use of heat-killed L. acidophilus (Lacteol LB) two capsules daily for one month modestly reduces pain and bloating and improves quality of life. The average weekly number of stools decreased by approximately 4.75. Also, the number of patients with watery stools was reduced from 54% at baseline to 19% (107535).

Atopic disease. Oral Lactobacillus acidophilus does not seem to be beneficial for preventing atopic disease in children. Details: A meta-analysis of clinical research shows that administering L. acidophilus during pregnancy, when breastfeeding, or to newborn infants might actually increase the risk of atopic sensitization (90251). However, the number of studies included in this analysis was limited.

Acne. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A preliminary clinical study shows that taking a specific probiotic product containing L. acidophilus 5 billion colony-forming units (CFUs), Lactobacillus delbrueckii subsp. bulgaricus 5 billion CFUs, and Bifidobacterium bifidum 20 billion CFUs (Trenev Trio/Healthy Trinity, Natren) twice daily along with minocycline once every evening for 12 weeks improves inflamed and non-inflamed acne lesions in 82% of patients, compared to only 67% of patients treated with either the probiotic combination or minocycline alone (90270).
Allergic rhinitis (hay fever). Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that drinking 250 mL of fermented milk containing L. acidophilus La-5 5 billion colony-forming units (CFUs), Lacticaseibacillus rhamnosus GG 50 billion CFUs, and Bifidobacterium animalis subsp. lactis BB-12 50 billion CFUs from 36 weeks' gestation until 3 months postpartum does not reduce the incidence of allergic rhinitis in the child at 6 years of age when compared with placebo milk (96893).
Atopic dermatitis (eczema). Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A meta-analysis of the available clinical research shows that intake of lactobacillus and bifidobacteria-based probiotics during gestation, followed by giving the probiotic to the newborn for the first 2-6 months of life, reduces the risk of developing atopic dermatitis by 40% over the next 6-24 months when compared with placebo, regardless of family history of atopy. However, only four of 10 studies included in the analysis used L. acidophilus as part of the probiotic combination; the results from these individual, small studies support the overall findings of the meta-analysis (107503). Some clinical research also shows that supplementation with 250 mL of fermented milk containing L. acidophilus La-5, Lacticaseibacillus rhamnosus GG, and Bifidobacterium animalis subsp. lactis BB-12 starting at 36 weeks' gestation and continuing until 3 months' postpartum, without supplementation in the infant, reduces the overall occurrence of atopic dermatitis in the child at 2 years of age. However, at 6 years of age, the effect appears to be inconclusive (96893).
Cancer. Although there has been interest in using oral Lactobacillus acidophilus for cancer prevention or treatment, there is insufficient reliable information about the clinical effects of L. acidophilus for this condition.
Canker sores. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A systematic review and meta-analysis of mainly small and preliminary clinical trials shows that taking lactobacilli probiotics has a small effect on pain from canker sores. However, the dose and duration of probiotic and the specific species, as well as endpoints and results from individual studies, are mixed. One small study shows that taking a combination of L. acidophilus, Lacticaseibacillus paracasei, Lacticaseibacillus rhamnosus, and Bifidobacterium animalis subsp. lactis reduces pain, but not the number of lesions or healing time, when compared with placebo. Another study shows that using lozenges providing inulin 0.13 gram along with L. acidophilus and B. animalis subsp. lactis 1.5 billion colony-forming units each reduces pain, but does not affect ulcer size or healing, when compared with Oracure gel (105146). Many of the individual studies may have been underpowered to detect a difference between groups.
Cholestasis. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in premature infants shows that the risk of developing cholestasis is reduced from 22% to 6% in those given a blend of L. acidophilus, bifidobacteria, and Enterococcus faecalis (Peifeikang powder, Shanghai Xinyi Pharmaceutical Company) at least 5 million colony-forming units three times daily, from birth until implementation of total parenteral nutrition, when compared with infants not given this powder. In the infants that developed cholestasis, the severity was reduced, resulting in a reduction in the rate of cholestatic liver injury, feeding intolerance, and necrotizing enterocolitis. The number of days to reach full enteral feeding, days to normal weight gain, and days of hospitalization were reduced by approximately 2.8, 2.1, and 1.7 days, respectively (103448).
Clostridioides difficile infection. It is unclear if oral Lactobacillus acidophilus is beneficial for preventing C. difficile occurrence or recurrence. Details: Current guidelines from the Infectious Diseases Society of America (IDSA) state that there is insufficient information to recommend administration of probiotics for the primary prevention of C. difficile-associated diarrhea (107538). Evidence from clinical and observational research investigating the effect of L. acidophilus on C. difficile occurrence or recurrence is weak. Most studies use this species in combination with one or more additional probiotic species, including as Bio-K+ CI1285, containing L. acidophilus CL1285 and L. casei LBC80R, and as Bio-K+ 50 Billion, containing L. acidophilus CL1285, Lacticaseibacillus casei LBC80R, and Lacticaseibacillus rhamnosus CLR2 (25494,90231,90934,95369,95403,107529). Observational research has found that providing the Bio-K+ 50 Billion product as 50-100 billion colony-forming units (CFUs) daily for 5 days to patients who are on antibiotics for at least 2 days reduces the hospital-wide incidence of C. difficile by approximately 40%. The incidence rate was decreased by at least 50% in the highest risk individuals taking this combination (107529).
Colic. Oral inactivated Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One clinical study in infants with colic shows that giving a specific multi-ingredient product (Colimil Plus, Milte Italia SPA) containing inactivated L. acidophilus 1 billion colony-forming units, lemon balm 65 mg, and German chamomile 9 mg twice daily for 4 weeks reduces crying time similarly to Limosilactobacillus reuteri DSM 17938 100 million CFUs daily (96278). It is unclear how L. acidophilus compares with no treatment.
Common cold. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in school children shows that taking a combination of L. acidophilus and Bifidobacterium bifidum (Infloran, Berna) 1 billion colony-forming units each twice daily for 3 months reduces the absolute percentage of school absence due to cold symptoms by 30% when compared with placebo (90286).
Constipation. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that stool frequency is increased and symptoms of functional constipation in adults are improved with the use of a specific combination product (Hexbio) providing L. acidophilus, Lacticaseibacillus casei, Lactobacillus delbrueckii subsp. lactis, Bifidobacterium bifidum, Bifidobacterium longum, and Bifidobacterium longum subsp. infantis 30 billion colony-forming units twice daily for 7 days (90266).
Critical illness (trauma). Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in critically ill, hospitalized adults shows that taking L. acidophilus LA-5 1.75 billion colony-forming units (CFUs), Lactiplantibacillus plantarum 500 million CFUs, Bifidobacterium animalis subsp. lactis BB12 1.75 billion CFUs, and Saccharomyces boulardii 1.5 billion CFUs twice daily for 15 days modestly reduces the risk of sepsis, as well as the length of stay in the ICU and hospital, when compared with placebo (107524).
Depression. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with major depression shows that taking L. acidophilus, Lacticaseibacillus casei, and Bifidobacterium bifidum daily for 8 weeks reduces symptoms of depression measured on the Beck Depression Inventory (BDI) when compared with placebo (99780). However, the validity of the results from this study is limited by incomplete reporting. For example, patient baseline BDI scores were not reported.
Diabetes. Oral Lactobacillus acidophilus seems to be beneficial for the treatment of gestational diabetes, although it is unclear if it is beneficial for treatment of type 1 or type 2 diabetes. Oral L. acidophilus is unlikely to be beneficial for the prevention of gestational diabetes. Details: Although some individual studies disagree, meta-analyses of clinical research in patients with gestational diabetes show that taking probiotics, most often L. acidophilus in combination with other species, improves glycemic indices such as fasting blood glucose and insulin sensitivity when compared with placebo (102288,104156). Some doses used in available studies include a combination of freeze-dried L. acidophilus, Lacticaseibacillus casei, and Bifidobacterium bifidum each as 2 billion colony-forming units (CFUs) per gram daily for 6 weeks (95416,98430), a total of 4 billion CFUs of a combination of L. acidophilus LA-5, Bifidobacterium animalis subsp. lactis BB-12, Streptococcus thermophilus STY-31, and Lactobacillus delbrueckii subsp. bulgaricus LBY-27 for 8 weeks starting at 24-28 weeks' gestation (96892), and a specific product containing L. acidophilus and 7 other probiotics (Visbiome, ExeGi Pharma) as a total of 112.5 billion CFUs twice daily for 8 weeks (107549). However, meta-analyses in patients with gestational diabetes show that taking probiotics including L. acidophilus does not reduce the risk for caesarean section birth, neonatal hypoglycemia, large for gestational age birth, or hypertensive disorders such as pregnancy-induced hypertension, pre-eclampsia, or eclampsia (102288,104156). Taking L. acidophilus does not seem to be effective for PREVENTING gestational diabetes. A large clinical trial shows that taking L. acidophilus LA1 7.5 billion CFUs, Bifidobacterium longum sp54 cs 1.5 billion CFUs, and Bifidobacterium bifidum sp9 cs 6 billion CFUs daily from 14-24 weeks' gestation does not reduce the incidence of gestational diabetes when compared with taking placebo (107520). Research on the use of L, acidophilus for type 2 diabetes is mixed. One clinical study shows that taking L. acidophilus along with six other probiotic strains (Familact) daily for 6 weeks reduces fasting blood glucose, but does not affect plasma insulin, when compared with placebo (99790). However, other clinical research shows that taking L. acidophilus 1 billion CFUs, Lacticaseibacillus rhamnosus 10 billion CFUs, and Bacillus coagulans GanedenBC30 (GBI-30, 6086) 100 billion CFUs with fructo-oligosaccharides 500 mg daily for 12 weeks modestly reduces fasting blood glucose and insulin and improves measures of insulin resistance when compared with placebo (107731). Also, taking a combination of L. acidophilus, Bifidobacterium bifidum, and Streptococcus thermophilus daily for 12 weeks does not reduce levels of fasting blood glucose or glycated hemoglobin (HbA1c) when compared with placebo (107521). A combination probiotic containing L. acidophilus has also been evaluated in children 2-12 years of age with new-onset type 1 diabetes. One clinical study shows that taking a specific combination product (Visbiome, ExeGi Pharma) providing 112.5 billion CFUs daily for 3 months modestly decreases HbA1c and insulin requirements when compared with placebo. Also, about three times as many children achieved remission, defined as insulin requirements of less than 0.5 U/kg daily and HbA1c less than 7%. However, C-peptide levels and the maintenance of residual pancreatic beta-cell function were not affected when compared with placebo (107497).
Diabetic nephropathy. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with diabetic nephropathy not taking antidiabetes drugs shows that taking a combination of L. acidophilus, Bifidobacterium bifidum, and Streptococcus thermophilus daily for 12 weeks modestly reduces the ratio of microalbuminuria/creatinine (mAlb/Cr), a marker of kidney damage, when compared with placebo. However, there was no effect on the estimated glomerular filtration rate (eGFR) (107521).
Diarrhea. Oral heat-killed L. acidophilus seems to reduce the duration of diarrhea in adults and children. Oral live L. acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in children with dysentery being treated with ceftriaxone shows that taking a specific combination probiotic sachet (Kidilact, Zisttakhmir Company) containing live L. acidophilus, Lacticaseibacillus casei, Lacticaseibacillus rhamnosus, Lactobacillus delbrueckii subsp. bulgaricus, Bifidobacterium longum subsp. infantis, Bifidobacterium breve, and Streptococcus thermophilus daily for 5 days modestly reduces the duration of diarrhea, hospitalization, and blood in diarrhea when compared with control (102417). Heat-killed L. acidophilus has also been investigated for the treatment of diarrhea. A meta-analysis of four small clinical studies in infants and children ages 1 month to 4 years shows that taking heat-killed L. acidophilus LB 20-30 billion colony-forming units (CFUs) daily for up to 5 days along with oral or intravenous rehydration therapy can modestly reduce the duration of diarrhea, primarily of non-rotaviral origin (90295). Also, preliminary clinical research in patients with functional chronic diarrhea shows that taking heat-killed L. acidophilus LB (Lacteol Fort, Laboratoire du Lacteol du Dr Boucard) as two capsules twice daily for a total of 20 billion cells daily for 4 weeks reduces daily stool frequency by 3.5, compared with a reduction of 1.2 in patients taking five chewable capsules three times daily of an unspecified strain of L. acidophilus (Lacidophilin, Tai Ge Pharma Ltd). Stool consistency, pain, distention, and total efficacy, defined as a decrease in mean symptoms by at least 40%, were also further improved in patients taking the heat-killed product (107537). The European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388) However, L. acidophilus is not a specific focus of the guidelines and most evidence is low quality.
HIV/AIDS. Although there has been interest in using oral Lactobacillus acidophilus for HIV/AIDS, there is insufficient reliable information about the clinical effects of L. acidophilus for this condition.
Hypercholesterolemia. It is unclear if oral Lactobacillus acidophilus is beneficial for lowering cholesterol levels; the available research is conflicting. Details: Two meta-analyses of clinical research show that taking fermented milk products containing L. acidophilus can reduce total cholesterol by about 14-19 mg/dL in adults with or without hypercholesterolemia. However, the effect of L. acidophilus on both total and LDL cholesterol levels is conflicting from available research (95396,95397,95399). A meta-analysis of nine small to moderate-sized clinical studies shows that taking a combination of L. acidophilus and Bifidobacterium animalis subsp. lactis reduces levels of total cholesterol when compared with placebo (107591). The included clinical trials evaluated patients with hypercholesterolemia, type 2 diabetes, nonalcoholic fatty liver disease (NAFLD), metabolic syndrome, and others. Taking L. acidophilus does not appear to improve high-density lipoprotein (HDL) cholesterol or triglyceride levels (95396,95397,95399). Doses used in some studies have included fermented milk products providing L. acidophilus 39 million to 2 billion CFUs daily, alone or along with other probiotic species, for up to 6 weeks (95396).
Hypertension. Although there has been interest in using oral Lactobacillus acidophilus for hypertension, there is insufficient reliable information about the clinical effects of L. acidophilus for this condition.
Lactose intolerance. It is unclear if oral Lactobacillus acidophilus is beneficial for lactose intolerance. Details: One small clinical trial shows that consuming 400 mL of a non-fermented milk product containing L. acidophilus 530 million colony-forming units (CFUs)/mL daily does not reduce symptoms of lactose intolerance or hydrogen breath test results when compared with milk without L. acidophilus (16737). However, another clinical trial shows that adding various L. acidophilus strains 800 million to 1 billion CFUs/mL to non-fermented milk improves hydrogen breath tests in patients with lactose intolerance (16738).
Lyme disease. Although there has been interest in using oral Lactobacillus acidophilus for Lyme disease, there is insufficient reliable information about the clinical effects of L. acidophilus for this condition.
Metabolic syndrome. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in elderly patients with metabolic syndrome shows that taking a combination of L. acidophilus PBS066-DSM 24,936, Lactiplantibacillus plantarum PBS067-DSM 24,937, and Limosilactobacillus reuteri PBS072-DSM 25,175 as 2 billion colony-forming units (CFUs) each, with inulin and fructo-oligosaccharides daily for 60 days, reduces the number of patients diagnosed with metabolic syndrome by 23%, compared with a 10% reduction in those taking placebo. In the probiotic group, there were modest improvements in waist circumference and levels of fasting plasma insulin, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and inflammatory mediators when compared with placebo. However, there were no significant differences between groups for fasting blood glucose or blood pressure. All patients in this study were on a Mediterranean-like standard diet (107560).
Necrotizing enterocolitis (NEC). It is unclear if oral Lactobacillus acidophilus is beneficial for NEC. Details: Most meta-analyses of clinical research show that giving lactobacilli enterally reduces the risk of NEC and/or severe NEC in preterm, mainly very low birth weight (VLBW), infants. Some meta-analyses support the use of lactobacilli in combination with bifidobacteria, as opposed to lactobacilli alone for reducing the risk of NEC. However, only a small number of the individual studies included in these analyses have investigated the effects of L. acidophilus, which was used as part of a combination probiotic and/or prebiotic product in all cases (95344,95351,103437,103445,104157,105162,105164).
Nonalcoholic fatty liver disease (NAFLD). Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In children with NAFLD, clinical research shows that taking a specific combination product (Prokid, Gostaresh Milad Pouya Company) containing L. acidophilus ATCC B3208 3 billion colony-forming units (CFUs), Lacticaseibacillus rhamnosus DSMZ 21690 2 billion CFUs, Bifidobacterium animalis subsp. lactis DSMZ 32269 6 billion CFUs, and Bifidobacterium bifidum ATCC SD6576 2 billion CFUs daily for 12 weeks normalizes liver sonography findings in 53% of children, compared with 17% of those taking placebo. In addition, levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are reduced by 30% and 25%, respectively. There was no effect on body mass index or blood lipids when compared with placebo (105156). However, taking L. acidophilus in combination with other probiotics does not seem to be beneficial in adults with NAFLD. Clinical research shows that taking yogurt 100 grams, containing L. acidophilus La-5 and Bifidobacterium animalis subsp. lactis Bb-12 40 million CFUs and vitamin D 1000 IU, daily for 3 months does not improve fasting blood glucose levels, insulin levels, blood pressure, or anthropometric indices when compared with unfortified yogurt (105174). Also, a small clinical trial shows that taking a combination of L. acidophilus BCMC 12,130, Lacticaseibacillus casei BCMC 12,313, Lactobacillus delbrueckii subsp. lactis BCMC 12,451, Bifidobacterium bifidum BCMC 02290, Bifidobacterium longum subsp. infantis BCMC 02129, and Bifidobacterium longum BCMC 02120 30 billion colony-forming units twice daily for 6 months has no beneficial effects on hepatic steatosis or fibrosis or on levels of liver enzymes, blood lipids, or fasting glucose, when compared with placebo (107523).
Obesity. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In combination with Bifidobacterium animalis subsp. lactis BS01, taking L. acidophilus LA02 2 billion colony-forming units (CFUs) daily for 6 weeks does not reduce body weight or body fat when compared with placebo in young, healthy females, only some of whom were overweight (103438). However, another clinical study shows that taking 50 billion CFUs of a specific combination of L. acidophilus, Lactiplantibacillus plantarum, Bifidobacterium bifidum, and B. animalis subsp. lactis (Lab4P) for 24 weeks reduces body weight by an additional 1.3 kg more than placebo (103439).
Polycystic ovary syndrome (PCOS). Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In patients with PCOS, clinical research shows that taking a combination of L. acidophilus T16 (IBRC-M10785), Lacticaseibacillus casei T2 (IBRC-M10783), and Bifidobacterium bifidum T1 (IBRC-M10771) 2 billion colony-forming units each, plus inulin 800 mg, daily for 12 weeks modestly reduces serum insulin and triglyceride levels and improves insulin resistance and insulin sensitivity when compared with placebo. However, it does not alter cholesterol or fasting glucose levels (105159).
Pouchitis. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Continuous oral treatment for one year with a specific concentrated formulation of L. acidophilus and other probiotics (Visbiome, ExeGi Pharma) as 6 grams (300-500 billion live bacteria per gram), daily for up 12 months seems to maintain remission of pouchitis in 85% of patients (6087,12769). Also, one small clinical study shows that taking a specific product (Trilac, Allergon AB) containing L. acidophilus 600 million colony-forming units (CFUs) per capsule, Lactobacillus delbrueckii subsp. bulgaricus 400 million CFUs per capsule, and Bifidobacterium bifidum 600 million CFUs per capsule, taken in doses of two capsules three times daily for 9 months, can reduce pouchitis severity and the number of patients experiencing pouchitis when compared to baseline (90296). The validity of these findings is limited by the lack of a comparator group.
Pregnancy-induced nausea and vomiting. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial shows that taking probiotics during pregnancy reduces the severity and duration of nausea and vomiting by 16% to 54%. There was also a small benefit on stool hardness. A specific probiotic (Probiotics 10, Nature's Bounty) was taken as 2 capsules daily for two back-to-back cycles of six days with probiotics and two days without. Each capsule contained a total of 10 billion colony-forming units (CFUs) of L. acidophilus La-14, Lactiplantibacillus plantarum 299v and DSM 15312, Lactobacillus delbrueckii subsp. bulgaricus Lb-87, Lacticaseibacillus paracasei DSM 13434 and Lpc-37, Ligilactobacillus salivarius Ls-33, Levilactobacillus brevis Lbr-35, Lacticaseibacillus casei Lc-11, and Bifidobacterium animalis subsp. lactis Bl-04, along with inulin 200 mg (107199).
Prematurity. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In premature infants, clinical research shows that taking a blend of L. acidophilus, bifidobacteria, and Enterococcus faecalis (Peifeikang powder, Shanghai Xinyi Pharmaceutical Company), at least 5 million colony-forming units three times daily from birth until implementation of total parenteral nutrition, reduces the rate of development of extrauterine growth retardation from 15% to 8% when compared with those not receiving this blend (103448).
Psoriasis. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with psoriasis shows that taking a mixture of probiotics for 8 weeks modestly improves overall symptoms and feelings of depression when compared with placebo. The percentage of patients achieving at least a 50% or 75% reduction in overall symptom score was 40% and 24%, respectively, in those taking the probiotic mixture, compared with 16% and 8% of those taking placebo. Each probiotic capsule was used twice daily and provided a total daily dose of 2.6 billion colony-forming units (CFUs) of L. acidophilus, Bifidobacterium bifidum, Bifidobacterium animalis subsp. lactis, and Bifidobacterium longum (107498).
Radiation-induced diarrhea. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with cervical cancer receiving radiotherapy with or without chemotherapy shows that taking a specific product (Biogurt, Fame Pharmaceuticals) containing L. acidophilus LA-5 and Bifidobacterium animalis subsp. lactis BB-12 as 1.75 billion lyophilized colony-forming units (CFUs) as a capsule three times daily throughout treatment reduces the risk of diarrhea by 28% when compared with placebo. The treatment group also used less loperamide (102285). Another small clinical trial in patients undergoing pelvic radiotherapy with weekly cisplatin shows that taking L. acidophilus and Bifidobacterium bifidum (Infloran, Laboratio Farmaceutico SIT) as 1 billion CFUs each, twice daily from seven days before starting radiotherapy and continuing during radiotherapy, reduces the incidence of moderate to severe diarrhea and the need for antidiarrheal medication when compared with placebo. Moderate to severe diarrhea occurred in 9% of patients using the probiotics, compared with 45% of those taking placebo (107580).
Respiratory tract infections. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children ages 3-5 years who attend daycare centers shows that taking a combination milk product containing 5 billion colony-forming units (CFUs) each of L. acidophilus and Bifidobacterium animalis (HOWARU Protect, Danisco) reduces the risk of experiencing fever, cough, and rhinorrhea by 45% when compared with placebo. Patients taking this combination experienced an average 2-day shorter duration of symptoms and were significantly less likely to use an antibiotic for their symptoms. Patients who took L. acidophilus without bifidobacterium also had a reduction in fever, cough, and use of antibiotics, but not rhinorrhea (16847). In healthy children aged 3-10 years, clinical research shows that taking 12.5 billion CFUs daily of a specific combination of L. acidophilus CUL21 and CUL60, Bifidobacterium bifidum CUL20, Bifidobacterium animalis subsp. lactis CUL34 (Lab4), and vitamin C 50 mg daily reduces the risk of cough by 16% and sore throat by 20%, and modestly reduces school absenteeism and antibiotic use when compared with placebo. However, nasal symptoms, fever, and wheezing were not reduced (106943). A different combination product containing L. acidophilus DDS-1 1 billion CFUs and B. animalis subsp. lactis UABLA-12 4 billion CFUs (Up4-Junior, UAS Laboratories) with fructo-oligosaccharides 50 mg has also been evaluated. Clinical research in children 3-12 years of age with a sick household member shows that taking this product daily for 2 weeks modestly shortens the duration of respiratory infections, but does not reduce the risk of developing an infection, when compared with placebo (98439). In overweight adults or adults with obesity, taking 50 billion CFUs of a specific combination of L. acidophilus, Lactiplantibacillus plantarum, B. bifidum, and B. animalis subsp. lactis (Lab4P) for 24 weeks reduces the overall likelihood of having upper respiratory tract infection symptoms, such as sneezing, cough, and blocked nose, by approximately 40% when compared with placebo (103439).
Rheumatoid arthritis (RA). Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study in patients with moderate-to-severe RA shows that taking capsules containing freeze-dried strains of L. acidophilus, Lacticaseibacillus casei, and Bifidobacterium bifidum daily for 8 weeks does not improve RA severity, the number of tender or swollen joints, or joint pain when compared with placebo (95418).
Rotaviral diarrhea. It is unclear if oral Lactobacillus acidophilus is beneficial for rotaviral diarrhea. Details: One preliminary clinical study shows that taking a combination of L. acidophilus AD031 2 billion colony-forming units (CFUs) and Bifidobacterium longum BORI 20 billion CFUs twice daily for 3 days reduces the duration of rotaviral diarrhea by an average of 3 days when compared with placebo (95334). However, one clinical study using a lower dose and different strain of L. acidophilus (La-14) 200 million CFUs twice daily for 5 days shows that this regimen does not reduce the duration of watery diarrhea or affect the viral load in children aged 9 months to 5 years with confirmed norovirus or rotavirus infection (96887). A small clinical study shows that heat-killed L. acidophilus LB 20-30 billion cells daily for up to 4 days can modestly reduce the duration of diarrhea in infants and children, some of which had confirmed rotavirus (90295).
Short bowel syndrome. Although there has been interest in using oral Lactobacillus acidophilus for short bowel syndrome, there is insufficient reliable information about the clinical effects of lactobacillus for this condition.
Small intestinal bacterial overgrowth (SIBO). Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in children with chronic diarrhea due to SIBO shows that taking a combination of lyophilized L. acidophilus 1.5 grams and Lacticaseibacillus casei 1.5 grams by mouth twice daily for 21 days decreases average daily stools by 1.5, but does not improve other symptoms, when compared with placebo (91143). Also, one preliminary clinical study shows that taking a total of 2 billion CFUs of L. acidophilus and Lacticaseibacillus rhamnosus (Lacidofil) daily for 4 weeks does not prevent the development of SIBO in children that started treatment with omeprazole 20 mg daily for epigastric pain (90262).
Travelers' diarrhea. It is unclear if oral Lactobacillus acidophilus is beneficial for the prevention of travelers' diarrhea. Details: A meta-analysis which included three clinical studies evaluating the use of L. acidophilus in adults traveling to different parts of the world found no benefit for the prevention of travelers' diarrhea when compared with placebo (101445). The effectiveness of this species may vary significantly based upon the destination of travel. Destinations in the same country can have different results, probably due to differences in bacteria and other microorganisms at different locations (10216).
Ulcerative colitis. Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: The best evidence of benefit is for a specific combination product (Visbiome, ExeGi Pharma). Doses of 3 grams (equivalent to 900 billion colony-forming units (CFUs)) once or twice daily have been used in combination with conventional treatment. In children aged 1-16 years, doses of 450-1800 billion CFUs for up to one year have been used (3261,14370,14371,16841,95337).. A meta-analysis of clinical research shows that taking this product as an adjunct to standard ulcerative colitis treatment can increase remissions rates in adults and children by about 1.7-fold when compared with standard treatment alone (95337). Although some contradictory evidence exists (3261,16841), most research shows that taking Visbiome or a combination of L. acidophilus LA-5 and Bifidobacterium animalis subsp. lactis BB-12 (Probio-Tec AB-25) does not prevent relapse in people who are already in remission (95337,95338).
Urinary tract infections (UTIs). Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In children aged 4 months to 5 years with a previous UTI, clinical research shows that taking a specific combination of L. acidophilus, Lacticaseibacillus rhamnosus, Bifidobacterium bifidum, and Bifidobacterium animalis subsp. lactis (Complete Probiotic Platinum) for 18 months increases the median time to the first incidence of recurrence by approximately 3 months and increases the percentage of children without a UTI during the study period from 83% to 97% (103436).
Vaginal candidiasis. It is unclear if oral or intravaginal Lactobacillus acidophilus is beneficial for vaginal candidiasis. Details: A combination of L. acidophilus, Lacticaseibacillus rhamnosus, Lactobacillus delbrueckii, and Streptococcus thermophilus (Femilac) given intravaginally, does not seem to reduce the risk of vaginal candidiasis infection following use of antibiotics (12108). There is also some evidence that eating yogurt enriched with L. acidophilus daily does not reduce the risk of recurrent vaginal candidiasis (1245).
Ventilator-associated pneumonia (VAP). Oral Lactobacillus acidophilus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that taking L. acidophilus LA-5 1.75 billion colony-forming units (CFUs), Lactiplantibacillus plantarum 500 million CFUs, Bifidobacterium animalis subsp. lactis BB12 1.75 billion CFUs, and Saccharomyces boulardii 1.5 billion CFUs twice daily for 15 days reduces the risk of VAP to 12%, compared with 28% in those taking placebo. Half of the dose was given onto the oropharynx and half via a nasogastric tube (107524). More evidence is needed to rate Lactobacillus acidophilus for these uses.

Safety view details

Below is general information about the safety of the known ingredients contained in the product Ultimate Flora Extra Care Probiotic 50 Billion. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS (Bifidobacterium lactis)

LIKELY SAFE ...when used orally and appropriately. Bifidobacterium lactis has been safely used alone or in combination with other probiotics in clinical trials lasting up to 12 weeks (92255,98502,105158,107572,107581,107586,110979,110985,110986,110992)(110993,110998,110999).

CHILDREN: LIKELY SAFE
when used orally and appropriately. Bifidobacterium lactis has been safely used alone or in combination with other probiotics in children of all ages for up to 15 months (3169,3458,92265,95381,95382,98736,105149,107582,107583,107585)(107587,107590,110984,110987,110988,110991,110994,110995). A combination probiotic containing B. lactis and Lactobacillus acidophilus (HOWARU Protect, Danisco) has been used safely for up to 6 months in children aged 3-5 years (16847). A specific combination of B. lactis, Bifidobacterium bifidum, and L. acidophilus (Complete Probiotic Platinum) has also been used safely for up to 18 months in children aged 4 months to 5 years (103436). In addition, in children ages 4-17 years, 1 billion CFUs of a 1:1:1 combination of B. lactis CECT 8145, Lacticasebacillus casei CECT 9104, and Bifidobacterium longum CECT 7347 has been used safely for 12 weeks (107531).

PREGNANCY AND LACTATION:
Insufficient reliable information available. A meta-analysis of four clinical trials shows that taking probiotics during pregnancy increases the relative risk of pre-eclampsia by 85% when compared with placebo. Although the specific effects of Bifidobacterium lactis are unclear from this analysis, three of the included studies used B. lactis in combination with Lacticaseibacillus rhamnosus (105185). More information is needed to determine if certain patients are at increased risk.

LIKELY SAFE ...when used orally and appropriately. Bifidobacterium breve has been safely used alone or in combination with other probiotics in clinical trials lasting up to one year (3261,6087,11379,12769,12775,14338,14370,14371,103447,111002)(111003,111005).

CHILDREN: LIKELY SAFE
when used orally and appropriately. Bifidobacterium breve has been safely used alone or in combination with other probiotics in children of all ages for up to 12 months (17726,35377,92256,103449,105150,105151,107497,107598,111001)(111004,111008,111015). Cases of bacteremia have occurred rarely (102416,107597).

PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of Bifidobacterium breve during pregnancy or lactation. However, there are currently no reasons to expect safety concerns when used appropriately.

LIKELY SAFE ...when used orally and appropriately. Bifidobacterium longum has been safely used alone or in combination with other probiotics in clinical trials lasting up to one year (1233,3261,6087,11379,12108,12769,13054,14334,14370,14371)(35382,35403,35424,103440,103446,105129,107593).

CHILDREN: LIKELY SAFE
when used orally and appropriately. Bifidobacterium longum has been safely used alone or in combination with other probiotics in clinical trials in children of all ages for up to 4 months (3162,35377,35383,35393,35406,35407,92266,98736,107497,107531). Cases of bacteremia have occurred rarely (102416).

PREGNANCY AND LACTATION: POSSIBLY SAFE
when used orally and appropriately, short-term. A combination of Bifidobacterium longum and Lacticaseibacillus rhamnosus has been used with apparent safety throughout pregnancy (105128,105144). Also, a combination of B. longum and Lacticaseibacillus paracasei has been used with apparent safety from 2 months prior to delivery until 2 months after delivery during lactation (90285).

LACTOBACILLUS ACIDOPHILUS (Lactobacillus salivarius, Lactobacillus rhamnosus, Lactobacillus bulgaricus)

LIKELY SAFE ...when used orally and appropriately. Lacticaseibacillus casei has been safely used alone or in combination with other probiotics in studies lasting up to 8 weeks (16740,90230).

CHILDREN: LIKELY SAFE
when used orally and appropriately. Lacticaseibacillus casei has been safely used alone in studies lasting up to 4 months (14373,14374,107544). Also, a specific mixture (Latopic, Biomed S.A.) providing 1 billion CFUs of L. casei ŁOCK 0919 50%, Lacticaseibacillus rhamnosus ŁOCK 0900 25%, and L. rhamnosus ŁOCK 0908 25% has been used with apparent safety for 3 months in children under 2 years of age (107510). In addition, in children ages 4-17 years, a 1:1:1 combination of L. casei CECT 9104, Bifidobacterium animalis subsp. lactis CECT 8145, and Bifidobacterium longum CECT 7347 providing 1 billion CFUs has been used with apparent safety for 12 weeks (107531).

PREGNANCY: POSSIBLY SAFE
when used orally and appropriately. A combination of Lacticaseibacillus casei, Lactobacillus acidophilus, and Bifidobacterium bifidum has been used with apparent safety for 6 weeks, starting at 24-28 weeks' gestation (95416,98430).

LACTATION:
There is insufficient reliable information available about the safety of Lacticaseibacillus casei during lactation. However, there are currently no reasons to expect safety concerns when used appropriately.

LACTICASEIBACILLUS PARACASEI (Lactobacillus paracasei)

LIKELY SAFE ...when used orally and appropriately. Lacticaseibacillus paracasei in combination with other probiotics has been safely used in studies lasting up to 9 months (6087,14370,14371,35393,35407,103440,105133,107555,107557). There is insufficient reliable information available about the safety of non-viable, heat-killed L. paracasei formulations when used orally.

CHILDREN: LIKELY SAFE
when used orally and appropriately. Lacticaseibacillus paracasei alone or in combination with Limosilactobacillus fermentum has been used with apparent safety for up to 3 months in children 1-18 years old (98440). Also, live or heat-killed L. paracasei LP-33 has been used with apparent safety for 30 days in children aged 5 years and older (107532). In children ages 2-12 years, a specific combination product (Visbiome, ExeGi Pharma) containing L. paracasei and seven other probiotics has been used safely for 3 months (107497). Also, L. paracasei has been used with apparent safety in combination with Lactiplantibacillus plantarum for up to 12 weeks (107556).

PREGNANCY AND LACTATION: POSSIBLY SAFE
when used orally and appropriately. A combination of Lacticaseibacillus paracasei and Bifidobacterium longum from 2 months prior to delivery until 2 months after delivery has been used with apparent safety (90285).

LACTIPLANTIBACILLUS PLANTARUM (Lactobacillus plantarum)

LIKELY SAFE ...when live Lactiplantibacillus plantarum is used orally and appropriately. L. plantarum has been safely used alone or in combination with other probiotics in studies lasting up to 9 months (6087,14370,14371,90255,105136,107515,107552,107555,107557,107559).

POSSIBLY SAFE ...when heat-killed Lactiplantibacillus plantarum is used orally and appropriately. Non-viable L. plantarum HK L-137 has been safely used in doses of 50 mg daily for 4 weeks or 10 mg daily for up to 12 months (107530). ...when L. plantarum is used intravaginally and appropriately. L. plantarum P17630 has been used with apparent safety daily for 6 days, then weekly for 16 weeks (98435).

CHILDREN: LIKELY SAFE
when used orally and appropriately. Lactiplantibacillus plantarum has been safely used in children aged 7-15 years for up to 4 weeks (107540). Also, L. plantarum has been used safely as a component of a combination probiotic product (Visbiome, ExeGi Pharma) in children aged 2-12 years for up to 3 months (107497) or in combination with Lacticaseibacillus paracasei for up to 12 weeks (107556).

PREGNANCY: POSSIBLY SAFE
when used orally and appropriately. Lactiplantibacillus plantarum (Lp299v, DSM 9843) has been used with apparent safety in doses of 10 billion colony-forming units (CFUs) daily in combination with iron, ascorbic acid, and folic acid daily from 10-12 weeks' gestation until delivery (107550).

LACTATION:
There is insufficient reliable information available about the safety of Lactiplantibacillus plantarum during lactation. However, there are currently no reasons to expect safety concerns when used appropriately.

LIKELY SAFE ...when used orally and appropriately. Lactobacillus acidophilus has been safely used as part of multi-ingredient probiotic products in studies lasting up to nine months (1731,6087,14370,14371,90231,90296,92255,103438,12775,107581). ...when used intravaginally and appropriately. L. acidophilus has been used safely in studies lasting up to 12 weeks (12108,13176,13177,90265). There is insufficient reliable information available about the safety of non-viable, heat-killed L. acidophilus formulations when used orally.

CHILDREN: LIKELY SAFE
when used orally and appropriately. Lactobacillus acidophilus has been safely used for up to 5 days (96887). Also, combination probiotics containing L. acidophilus have been used with apparent safety in various doses and durations. L. acidophilus has been combined with Bifidobacterium animalis (HOWARU Protect, Danisco) for up to 6 months in children 3-5 years old (16847), with Bifidobacterium bifidum for 6 weeks (90602,96890), with Bifidobacterium bifidum and Bifidobacterium animalis subsp. lactis (Complete Probiotic Platinum) for 18 months in children 4 months to 5 years of age (103436), and in a specific product (Visbiome, ExeGi Pharma) containing a total of 8 species for 3 months in children 2-12 years old (107497).

PREGNANCY: POSSIBLY SAFE
when used orally and appropriately. A combination of Lactobacillus acidophilus, Lacticaseibacillus casei, and Bifidobacterium bifidum has been used with apparent safety for 6 weeks, starting at 24-28 weeks' gestation (95416,98430).

LACTATION:
There is insufficient reliable information available about the safety of Lactobacillus acidophilus during lactation. However, there are currently no reasons to expect safety concerns when used appropriately.

BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS (Bifidobacterium lactis)

Interactions with Drugs view details

Below is general information about the interactions of the known ingredients contained in the product Ultimate Flora Extra Care Probiotic 50 Billion. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

ANTIBIOTIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = D

Theoretically, taking Bifidobacterium lactis with antibiotic drugs might decrease the effectiveness of B. lactis.

Details

Since B. lactis preparations usually contain live and active organisms, simultaneously taking antibiotics might kill a significant number of the organisms (1740,22802). Tell patients to separate administration of antibiotics and B. lactis preparations by at least 2 hours.

ANTIBIOTIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = D

Theoretically, taking Bifidobacterium breve with antibiotic drugs might decrease the effectiveness of B. breve.

Details

Since B. breve preparations usually contain live and active organisms, simultaneously taking antibiotics might kill a significant number of the organisms (1740,22802). Tell patients to separate administration of antibiotics and B. breve preparations by at least 2 hours.

ANTIBIOTIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Moderate • Occurrence = Probable • Level of Evidence = D

Theoretically, taking Bifidobacterium longum with antibiotic drugs might decrease the effectiveness of B. longum.

Details

Since B. longum preparations usually contain live and active organisms, simultaneously taking antibiotics might kill a significant number of the organisms (1740,22802). Tell patients to separate administration of antibiotics and B. longum preparations by at least 2 hours.

LACTOBACILLUS ACIDOPHILUS (Lactobacillus salivarius, Lactobacillus rhamnosus, Lactobacillus bulgaricus)

ANTIBIOTIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Mild • Occurrence = Probable • Level of Evidence = D

Theoretically, taking Lacticaseibacillus casei with antibiotic drugs might decrease the effectiveness of L. casei.

Details

L. casei preparations usually contain live and active organisms. Therefore, simultaneously taking antibiotics might kill a significant number of the organisms (1740). Tell patients to separate administration of antibiotics and L. casei preparations by at least two hours.

LACTICASEIBACILLUS PARACASEI (Lactobacillus paracasei)

ANTIBIOTIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Mild • Occurrence = Probable • Level of Evidence = D

Theoretically, taking Lacticaseibacillus paracasei with antibiotic drugs might decrease the effectiveness of L. paracasei.

Details

L. paracasei preparations usually contain live and active organisms. Therefore, simultaneously taking antibiotics might kill a significant number of the organisms (1740). Tell patients to separate administration of antibiotics and L. paracasei preparations by at least two hours.

LACTIPLANTIBACILLUS PLANTARUM (Lactobacillus plantarum)

ANTIBIOTIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Mild • Occurrence = Probable • Level of Evidence = D

Theoretically, taking Lactiplantibacillus plantarum with antibiotic drugs might decrease the effectiveness of L. plantarum.

Details

L. plantarum preparations usually contain live and active organisms. Therefore, simultaneously taking antibiotics might kill a significant number of the organisms (1740). Tell patients to separate administration of antibiotics and L. plantarum preparations by at least two hours.

ANTIBIOTIC DRUGS

Interaction Rating = Moderate Be cautious with this combination.

Severity = Mild • Occurrence = Probable • Level of Evidence = D

Theoretically, taking Lactobacillus acidophilus with antibiotic drugs might decrease the effectiveness of L. acidophilus.

Details

L. acidophilus preparations usually contain live and active organisms. Therefore, simultaneously taking antibiotics might kill a significant number of the organisms (1740). Tell patients to separate administration of antibiotics and L. acidophilus preparations by at least two hours.

Report an Adverse Reaction to Ultimate Flora Extra Care Probiotic 50 Billion

Adverse Effects view details

Below is general information about the adverse effects of the known ingredients contained in the product Ultimate Flora Extra Care Probiotic 50 Billion. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.

BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS (Bifidobacterium lactis)

General ...Orally, Bifidobacterium lactis seems to be well tolerated by most patients.
Most Common Adverse Effects:
Orally: Diarrhea.

Dermatologic ...In clinical research, two cases of rash, one with itching, were reported by patients taking a combination of Bifidobacterium lactis BB-12, Lacticaseibacillus paracasei F19, and Lactobacillus acidophilus La5. However, it is not clear if these adverse effects were due to B. lactis, other probiotics, or the combination, or if the events were idiosyncratic (90236).

Gastrointestinal ...Bloating and flatulence have been reported with probiotic use; however, these adverse effects have not been reported from ingestion of Bifidobacterium lactis in particular. When taken orally, B. lactis can cause diarrhea and other gastrointestinal complaints in children (3169,95381,105149). Gastrointestinal complaints including worsening diarrhea, abdominal pain, constipation, stomach burn, and flatulence have been reported rarely (110986,110999).

Immunologic ...There have been cases of Bifidobacterium bacteremia in critically ill patients (102416,107599). These cases are rare and none seem to be due to Bifidobacterium lactis alone.
A specific preparation (NBL probiotic ATP, Nobel) containing B. lactis, Lacticaseibacillus casei, Lacticaseibacillus rhamnosus, Lactiplantibacillus plantarum, fructo-oligosaccharides, galacto-oligosaccharides, colostrum, and lactoferrin was found to be a significant risk factor for vancomycin-resistant Enterococcus colonization in premature infants. Although there was no direct link to determine causation, it was hypothesized that the probiotic mixture helped to mediate the acquisition and transfer of antibiotic resistance genes (96890).

General ...Orally, Bifidobacterium breve seems to be well tolerated by most patients.
Serious Adverse Effects (Rare):
Orally: There is concern that B. breve may cause bacteremia in certain patients.

Gastrointestinal ...Bloating and flatulence have been reported with probiotic use; however, these adverse effects have not been reported from ingestion of Bifidobacterium breve in particular.

Immunologic ...There have been rare cases of Bifidobacterium bacteremia related to probiotic use in critically ill infants and adults (102416,107597,107599). In addition, cases of B. breve bacteremia have occurred in preterm infants or young children using probiotics (102416,107597). In a review of 298 term and preterm infants who were admitted to the neonatal intensive care unit of a hospital in Japan and received B. breve BBG-01 over a five-year period, bacteremia occurred in six patients (2%). Concomitant conditions included gastrointestinal perforation, food-induced enterocolitis syndrome, adhesive ileus, ileal volvulus, and aspiration pneumonia following esophageal atresia repair (107597). In one case report, B. breve BBG-01 was provided to an infant starting two days after birth and the day of surgery for an omphalocele. The infant also had bilious gastric fluid with elevated inflammatory markers. It is thought that the intestinal surgical repair might have led to the translocation of the ingested B. breve (107596).
Some cases of B. breve bacteremia do not seem to be directly related to probiotic use. There have been rare cases of B. breve bacteremia and necrotizing fasciitis in patients with type 2 diabetes. One patient had pre-existing chronic diabetic foot ulcers and the other had abscesses near the groin (111007,111011). A childhood history of frequent consumption of fermented beverages containing B. breve was thought to have resulted in B. breve in the intestinal flora of one of these patients, aged 42 years (111011). However, it is unclear if consumption of an unknown quantity of B. breve more than 20 years previously would play a role in this outcome. There is also a rare case of ventriculoperitoneal shunt B. breve infection possibly related to poor oral hygiene and dentition (111014).

General ...Orally, Bifidobacterium longum seems to be well tolerated by most patients.
Most Common Adverse Effects:
Orally: Diarrhea.
Serious Adverse Effects (Rare):
Orally: There is concern that B. longum may cause bacteremia in certain patients.

Gastrointestinal ...Bloating and flatulence have been reported with probiotic use; however, these adverse effects have not been reported from ingestion of Bifidobacterium longum in particular. When taken orally, probiotic combinations containing B. longum can cause diarrhea in children (16841). Flatulence (107497,107520) and bloating (107497) have also been reported in clinical trials using probiotic combinations containing B. longum.

Immunologic ...There have been rare cases of Bifidobacterium bacteremia in critically ill infant and adult patients (102416,107599). At least nine cases of Bifidobacterium longum bacteremia, sometimes presenting as sepsis, have occurred in preterm infants using probiotics (102416). In one case report, a 15-month-old female infant with congenital heart defects and recent surgery to replace a mechanical heart valve developed Bifidobacterium sepsis after being treated with IV antibiotics, extracorporeal membrane oxygenation (ECMO), and oral probiotics containing B. longum. It was thought that ECMO contributed to translocation of bifidobacteria from the gut and into the blood (102416). Cases of sepsis related to B. longum have also occurred in adults; however, association with supplementation is unlikely. In one case, sepsis with B. longum occurred following acupuncture. This was likely due to needle contamination and not to supplementation (1236).

LACTOBACILLUS ACIDOPHILUS (Lactobacillus salivarius, Lactobacillus rhamnosus, Lactobacillus bulgaricus)

General ...Orally, Lacticaseibacillus casei is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Serious Adverse Effects (Rare):
Orally: There is concern that lactobacilli may cause infections in some people.

Gastrointestinal ...Orally, taking Lacticaseibacillus casei in combination with other probiotics may cause gastrointestinal side effects including abdominal pain (90291); however, these events are uncommon.

Immunologic ...Since Lacticaseibacillus casei preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients. Some lactobacilli species have been isolated in some cases of bacteremia, sepsis, splenic abscess, endocarditis, necrotizing fasciitis, pancreatic necrosis, and meningoencephalitis. Most of these cases are thought to be due to the translocation of bacteria from other locations in the body in which they occur naturally, such as the oral cavity and gastrointestinal tract. The majority of cases are not related to the use of probiotic supplements and none have been associated with the use of L. casei (107543).
A specific probiotic preparation (NBL probiotic ATP, Nobel) containing L. casei, Lacticaseibacillus rhamnosus, Lactiplantibacillus plantarum, Bifidobacterium animalis subsp. lactis, fructo-oligosaccharides, galacto-oligosaccharides, colostrum, and lactoferrin was found to be a significant risk factor for vancomycin-resistant Enterococcus colonization in premature infants. Although there was no direct link to determine causation, it was hypothesized that the probiotic mixture helped to mediate the acquisition and transfer of antibiotic resistance genes (96890).

LACTICASEIBACILLUS PARACASEI (Lactobacillus paracasei)

General ...Orally, Lacticaseibacillus paracasei is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Serious Adverse Effects (Rare):
Orally: There is concern that Lacticaseibacillus paracasei may cause infections in some people.

Dermatologic ...Orally, in one clinical trial, a combination of Lacticaseibacillus paracasei subsp. paracasei F19, Lactobacillus acidophilus La-5, and Bifidobacterium animalis subsp. lactis BB-12 was associated with two cases of rash, one with itching. However, it is not clear if these adverse effects were due to L. paracasei, other ingredients, the combination, or if the events were idiosyncratic (90236).

Gastrointestinal ...Orally, taking Lacticaseibacillus paracasei alone or in combination with other probiotics may cause gastrointestinal side effects including dyspepsia (105133), flatulence (107497), and bloating (107497); however, these events are uncommon.
There are at least five case reports of acute cholecystitis for which a lactobacilli was thought to be the primary pathogen. In a 66-year-old female, vancomycin-resistant L. paracasei was the primary pathogen resulting in peritonitis secondary to a cholecystitis-induced gallbladder perforation. Although the patient reportedly ate 96-128 oz of yogurt each day, this yogurt was not believed to be associated with the cholecystitis (103443).

Immunologic ...Since Lacticaseibacillus paracasei preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients. Lactobacilli species, including L. paracasei, have been isolated in some cases of bacteremia, sepsis, splenic abscess, endocarditis, necrotizing fasciitis, pancreatic necrosis, and meningoencephalitis. Most cases of L. paracasei infection are thought to be due to the translocation of bacteria from other locations in the body in which it occurs naturally, such as the oral cavity and gastrointestinal tract (107543). However, there are case reports of L. paracasei infections thought to be at least partially related to dietary or supplemental intake (90254,107546,95393). In a 77-year-old male who consumed yogurt containing L. paracasei daily, L. paracasei bacteremia with endocarditis was thought to be related to bacterial translocation from the colon following a colonoscopy (90254). In a 78-year-old male, L. paracasei bacteremia and endocarditis was thought to be related to daily use of probiotics; however, the specific species included in the product were not mentioned. Also, the patient was diagnosed with an aortic valve stenosis and had undergone dental treatment approximately 6 months previously, possibly increasing the risk for development of bacteremia (95393). In an immunocompetent 45-year-old male with no history of heart disease, consumption of yogurt containing L. paracasei for about 2.5 years was thought to be associated with the development of endocarditis (107546).

LACTIPLANTIBACILLUS PLANTARUM (Lactobacillus plantarum)

General ...Orally and intravaginally, Lactiplantibacillus plantarum is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Serious Adverse Effects (Rare):
Orally: There is concern that lactobacillus may cause infections in some people.

Gastrointestinal ...Orally, taking Lactiplantibacillus plantarum may cause gastrointestinal side effects including diarrhea, loose stools, stomach pain, rumbling, bloating, and flatulence (90271,107497,107556,107557); however, these events are uncommon.

Immunologic ...Since Lactiplantibacillus plantarum preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients. Lactobacilli species, including L. plantarum, have been isolated in some cases of bacteremia, sepsis, splenic abscess, endocarditis, necrotizing fasciitis, pancreatic necrosis, and meningoencephalitis. Most cases of L. plantarum infection are thought to be due to the translocation of bacteria from other locations in the body in which they occur naturally, such as the oral cavity and gastrointestinal tract (107543). However, there are also rare case reports of pathogenic infections possibly related to intake of L. plantarum supplements in these populations. In one case report, the diagnosis of L. plantarum bacteremia in a regular consumer of the fermented food Nukazuk was thought to be related to the eventual diagnosis of rectal cancer (107551).
A specific probiotic preparation (NBL probiotic ATP, Nobel) containing L. plantarum, Lacticaseibacillus casei, Lacticaseibacillus rhamnosus, Bifidobacterium animalis subsp. lactis, fructo-oligosaccharides, galacto-oligosaccharides, colostrum, and lactoferrin was found to be a significant risk factor for vancomycin-resistant Enterococcus colonization in premature infants. Although there was no direct link to determine causation, it was hypothesized that the probiotic mixture helped to mediate the acquisition and transfer of antibiotic resistance genes (96890).

Neurologic/CNS ...Orally, use of Lactiplantibacillus plantarum 299v 10 billion colony-forming units daily has been associated with one case of transient vertigo in one clinical trial (90249).

General ...Orally and intravaginally, Lactobacillus acidophilus is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Intravaginally: Vaginal discharge.
Serious Adverse Effects (Rare):
Orally: There is concern that lactobacilli may cause infections in some people.

Dermatologic ...Orally, in one clinical trial, a combination of Lactobacillus acidophilus La-5, Lacticaseibacillus paracasei subsp. paracasei F19, and Bifidobacterium animalis subsp. lacltis BB-12 was associated with two cases of rash, one with itching. However, it is not clear if these adverse effects were due to L. acidophilus, other ingredients, the combination, or if the events were idiosyncratic (90236).

Gastrointestinal ...Orally, taking Lactobacillus acidophilus in combination with other probiotics may cause gastrointestinal side effects including epigastric discomfort (90239), abdominal pain (90239,90291), dyspepsia (90239), flatulence (107497,107520), bloating (107497), vomiting (107537), and burping (90239); however, these events are uncommon.

Genitourinary ...Intravaginally, cream containing Lactobacillus acidophilus has been shown to cause increased vaginal discharge in about 5% of patients, compared to about 1% of patients receiving placebo cream (90237).

Immunologic ...Since Lactobacillus acidophilus preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients. L. acidophilus has been isolated in some cases of bacteremia, sepsis, splenic abscess, endocarditis, necrotizing fasciitis, pancreatic necrosis, and meningoencephalitis. Most of these cases are thought to be due to the translocation of bacteria from other locations in the body in which they occur naturally, such as the oral cavity and gastrointestinal tract (107543).

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