FloraSport 20B by Thorne

POSSIBLY EFFECTIVE

• 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).

POSSIBLY INEFFECTIVE

• 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).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• 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 or safe 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). A network meta-analysis of two clinical studies shows that taking a combination probiotic containing B. lactis Bb-12, Bifidobacterium longum subsp. infantis Bb-02, and Streptococcus thermophilus TH-4, reduces the risk of NEC by 71% when compared with control (102437). Despite these findings, guidance among regulatory agencies and clinical organizations varies with respect to the use of probiotics in very low birth weight infants under 1000 grams. The US Food and Drug Administration (FDA) warns that preterm infants given probiotics are at risk of serious infections caused by the bacteria or fungi contained in probiotics due to cases reported in this group of infants (111610). Also, The American Academy of Pediatrics does not support the routine administration of probiotics to preterm infants, particularly those with a birth weight below 1000 grams, due to conflicting data on safety and efficacy and potential for harm in this vulnerable population (111608). The Canadian Paediatric Society, the American Gastroenterological Association, and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition state that probiotic combinations may be of benefit in reducing the incidence of NEC in preterm neonates over 1000 grams. However, B. lactis is not specifically recommended (103003,111609,111611).
• 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.

(Read more about BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS)

POSSIBLY EFFECTIVE

• 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). In children ages 2-5 years with allergic rhinitis, clinical research shows that taking fermented milk (Danone) containing L. paracasei DN-114 011 10 billion CFUs daily does not increase the time free from rhinitis episodes, the mean duration of episodes, or the cumulative number of episodes, when compared with taking a control milk. However, the number of episodes was reduced between months 3-9. The fermented milk was made with the yogurt cultures Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus (112512). Heat-killed L. paracasei has also been investigated. One clinical trial in adults with chronic allergy symptoms shows that taking heat-killed L. paracasei IJH-SONE68 1040 mg or 500,000 cells daily for 12 weeks modestly improves self-reported symptoms, including frequencies of sneezing and blowing, watery eyes, and head dullness, when compared with taking placebo. There was no effect on nasal congestion or itchy eyes (111939). Also, 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. Small clinical trials suggest that heat-killed L. paracasei does not seem to be 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 adults treated with conventional topical corticosteroid and tacrolimus, a small clinical trial shows that taking heat-killed L. paracasei K71 200 billion cells daily for 12 weeks does not improve skin symptom severity, quality of life, or use of topical medication, when compared with taking placebo (111947). Also, in infants ages 4-30 months with atopic dermatitis, clinical research 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 in healthy individuals shows that taking an acidified milk drink providing L. paracasei (L. casei 431) 1 billion colony-forming units (CFUs) daily for 21 days before and after receiving the seasonal influenza vaccination does not affect the number, duration, or severity of common cold or influenza-like illness episodes when compared with taking placebo. However, there was a modest reduction in the duration of illness 4-6 weeks after vaccination (111937). L. paracasei has also been examined in combination with L. plantarum. Clinical research shows that taking L. plantarum HEAL 9 (DSM 15312) and L. paracasei 8700:2 (DSM 13434) (Probi Defendum, Probi AB) 1 billion 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. L. paracasei has also been investigated as part of fermented milk. A clinical trial in elderly nursing home residents shows that drinking two bottles of fermented milk containing L. paracasei Shirota daily for 6 months does not reduce the risk of developing respiratory symptoms when compared with placebo milk (96885). However, a small clinical study in healthy, male, middle-aged office workers shows that drinking a fermented milk made with L. paracasei Shirota for 12 weeks reduces the incidence and duration of the common cold by 59% when compared with a control milk (98426). Also, a clinical study in children aged 3-6 years attending daycare shows that drinking a fermented milk product containing L. paracasei (Actimel, Danone) 200 grams daily for 3 months reduces the risk of developing the common cold, the most common upper respiratory tract infection in these children, by around 18% when compared with a control milk product. The fermented milk product did not affect medication use or sick leave from daycare (96882).

POSSIBLY INEFFECTIVE

• Constipation. Oral Lacticaseibacillus paracasei does not seem to be beneficial for constipation. Details: Meta-analyses of two or three clinical trials in adults with functional constipation show that taking L. paracasei Shirota 6.5-30 billion colony-forming units daily for 4 weeks does not appear to improve gut transit time or increase the number of stools (95342). Also, clinical research in patients with constipation shows that taking a combination of L. paracasei Lpc-37 2.5 billion colony-forming units daily for 2 weeks along with Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp. lactis strains Bl-04, Bi-07, and HN019, does not improve bloating, abdominal pain, intestinal transit time, frequency of bowel movements, or stool consistency when compared with placebo. There was a small beneficial effect on flatulence (110979).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. It is unclear if topical heat-killed Lacticaseibacillus paracasei is beneficial for acne. Details: Preliminary clinical research in patients with mild to moderate acne shows that topical application with a lotion providing the cell-free supernatant of L. paracasei MSMC 39-1 twice daily for 4 weeks is as effective as a lotion containing 2.5% benzoyl peroxide for decreasing redness and the inflammatory acne lesion count. There was no effect of either lotion of non-inflammatory acne lesion count (111945). This study is limited by the lack of blinding to lotion type.
• Alcohol-related liver disease. It is unclear if oral Lacticaseibacillus paracasei is beneficial in patients with alcohol-related liver disease. Details: Clinical research in patients with alcohol-related liver disease shows that taking fermented milk providing L. paracasei Shirota daily for 60 days reduces levels of triglycerides and low-density lipoprotein (LDL) cholesterol by 27% and 24%, respectively, compared with taking placebo. There was also an improvement in liver function, based on modest improvements in various liver markers, including alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, and bilirubin. Patients consumed L. paracasei 20 billion colony-forming units daily (111958).
• Antibiotic-associated diarrhea. It is unclear if oral Lacticaseibacillus paracasei is beneficial for preventing antibiotic-induced diarrhea. Details: Most clinical research has investigated the effect of L. paracasei in combination with other probiotics. A meta-analysis of 3 clinical trials in hospitalized or outpatient adults shows that taking L. paracasei in combination with up to 8 other probiotic strains reduces the risk of AAD by 40% when compared with taking placebo (107635). One of these studies, a small clinical trial in patients taking amoxicillin 500 mg twice daily for 7 days, used a specific combination probiotic (Ecologic AAD) twice daily for 14 days. 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 (CFUs) each daily (95405). In addition, one small clinical study in hospitalized adults shows that consuming a 97 mL drink (Actimel, Danone) containing L. paracasei 100 CFUs/mL, Streptococcus thermophilus 100 million CFUs/mL, and Lactobacillus delbrueckii subsp. bulgaricus 10 million CFUs/mL twice daily while taking antibiotics reduces the odds of developing AAD by 75% when compared with a milkshake without probiotics (16740). However, an additional large clinical trial in children aged 3 months and up shows that taking L. paracasei in combination with other probiotics does not reduce the risk of antibiotic-associated diarrhea when compared with taking placebo, when the more stringent definition is considered excluding diarrhea of other etiologies. However, the risk of diarrhea of any etiology is reduced by 35%. The probiotic supplement provided a total of 10 billion CFUs of L. paracasei W20, Lactobacillus acidophilus W37, Lactobacillus acidophilus W55, Bifidobacterium bifidum W23, Bifidobacterium animalis subsp. lactis W51, Lactiplantibacillus plantarum W62, Lacticaseibacillus rhamnosus W71, and Ligilactobacillus salivarius W24 daily from the first day of antibiotic treatment until 7 days after treatment ended (110969). It is unclear if any benefits are due to L. paracasei, the other ingredients, or their combination. L. paracasei has also been investigated alone. In hospitalized patients with spinal cord injury, preliminary clinical research shows that 17.1% of patients taking L. paracasei Shirota 6.5 billion CFUs daily in a probiotic drink (Yakult light) developed diarrhea compared with 54.9% of those given only routine care. L. paracasei was taken during antibiotic treatment and for an additional 7 days (111955). This study is limited by a lack of blinding.
• Antituberculosis treatment-associated adverse effects. It is unclear if oral Lacticaseibacillus paracasei is beneficial for preventing adverse effects associated with antituberculosis treatment. Details: Preliminary clinical research shows that taking L. paracasei 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).
• 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). In children ages 2-5 years with asthma, clinical research shows that taking fermented milk (Danone) containing L. paracasei DN-114 011 10 billion colony-forming units daily does not increase the time free from asthma episodes, the mean duration of episodes, or the cumulative number of episodes, when compared with taking a control milk. The fermented milk was made with the yogurt cultures Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus (112512).
• 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.
• Colic. Although there has been interest in using oral Lacticaseibacillus paracasei for colic, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
• Colorectal cancer. It is unclear if oral Lacticaseibacillus paracasei is beneficial for colorectal cancer prevention. Details: Clinical research in patients with previous removal of colorectal tumors shows that taking at least 1.5 billion colony-forming units L. paracasei Shirota 3 times daily for 4 years does not prevent the development of new colorectal tumors when compared with not taking L. paracasei. However, taking L. paracasei reduces the occurrence of colorectal tumors with moderate or severe atypia by 35%. Half of the patients included in this research were also consuming wheat bran biscuits (111959).
• 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).
• Depression. Although there has been interest in using oral Lacticaseibacillus paracasei for depression, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
• 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 limited. One large clinical study shows that taking a fermented milk product containing L. paracasei DN-114 001 (e.g., DanActive, Dannon) 100 million CFUs per milliliter for up to 4 months helps to prevent acute, non-rotaviral diarrhea in children ages 6-24 months (14374).
• Exercise-induced muscle damage. It is unclear if oral Lacticaseibacillus paracasei is beneficial for exercise-induced muscle damage. Details: Clinical research in adults shows that taking L. paracasei L-PS23 20 billion colony-forming units or heat-killed L. paracasei HK-PS23 20 billion cells daily modestly reduces muscle strength loss and improves measures of muscle recovery in the 48 hours following exercise-induced muscle damage when compared with taking placebo. L. paracasei was taken for 6 weeks prior to inducing muscle damage and continued for an additional 48 hours (111940).
• Exercise-induced respiratory infections. It is unclear if oral Lacticaseibacillus paracasei is beneficial for preventing respiratory infections related to exercise. Details: Clinical research in endurance athletes shows that taking a probiotic supplement containing L. paracasei 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). However, other clinical research shows that taking L. paracasei Shirota 6.5 billion CFUs daily for 4 months during winter endurance training modestly reduces the proportion of athletes with at least 1 week with upper respiratory tract illness symptoms by 27%, and the total number of episodes by 0.9, when compared with taking placebo. There was no difference in symptom severity or duration (111950).
• Fractures. It is unclear if oral Lacticaseibacillus paracasei 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. paracasei 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 paracasei is beneficial in children with H. pylori infection. Details: Clinical research in H. pylori-colonized children aged 6 to 17 years shows that taking a fermented dairy product containing live or heat-killed L. paracasei ST11 (Chamyto, Nestle'-Chile SA, Santiago, Chile) 1.6 billion cells or colony-forming units 5 days each week for 4 weeks does not reduce H. pylori colonization when compared with the beverage without L. paracasei. The beverages were fermented with Lactobacillus helveticus (110934).
• 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. It is unclear if oral Lacticaseibacillus paracasei is beneficial for hypercholesterolemia. Details: A small clinical trial in patients with hypercholesterolemia shows that taking 10.5 billion colony-forming units of L. paracasei TISTR 2593 daily for 90 days reduces levels of low-density lipoprotein cholesterol by about 11% when compared with taking placebo. There was no effect on total or high-density lipoprotein cholesterol or triglyceride levels (111938).
• Insomnia. It is unclear if oral Lacticaseibacillus paracasei is beneficial for improving sleep quality. Details: A small clinical trial in students shows that taking fermented milk containing L. paracasei Shirota daily for 11 weeks, starting 8 weeks prior to a stressful standardized examination, modestly reduces feelings of sleepiness upon rising and increases sleep length when compared with a non-fermented placebo milk. Objective measures of sleep latency were also reduced. There was no effect on total sleep time or sleep efficacy (111949).
• 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 or L. paracasei Shirota 13 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 most symptoms of IBS (90236,94696,94697,103440,111952). L. paracasei has also been examined in combination with other ingredients. In patients 60 years and older with IBS, taking L. paracasei DKGF1 100 billion CFUs daily with Opuntia humifusa extract more than doubles the proportion of patients with improvements in self-reported overall symptoms during more than 2 of the 4 weeks of treatment when compared with taking placebo. Response rates for abdominal pain and psychological well-being were also improved. However, there were no differences between groups for response rates related to improvements in gas or bloating (111943).
• Japanese cedar pollinosis. It is unclear if oral Lacticaseibacillus paracasei is beneficial for Japanese cedar pollinosis. Details: Clinical research in patients with Japanese cedar pollinosis shows that taking L. paracasei KW3110 at least one trillion colony-forming units daily for 12 weeks starting 1 month before the start of the pollen season does not improve nasal symptoms during peak season when compared with taking placebo (111948).
• Lower respiratory tract infections. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children ages 3-6 years shows that taking taking fermented milk (DanActive, Dannon) containing L. paracasei DN-114 011 20 billion colony-forming units daily for 90 days does not prevent lower respiratory tract infections when compared with taking a control non-fermented milk. The fermented milk was made with the yogurt cultures Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus (112515).
• 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.
• Migraine headache. It is unclear if oral Lacticaseibacillus paracasei is beneficial for migraine treatment. Details: Clinical research in patients with moderate to severe vestibular symptoms associated with migraine headaches shows that taking L. paracasei Shirota 20 billion colony-forming units daily for 4 months modestly reduces symptoms of vertigo and dizziness. The number of attacks with vertigo each week was reduced by 1.6, compared with 0.9 in patients taking placebo. Both vertigo and dizziness severity, as well as feelings of anxiety and depression, were also modestly reduced (111951). Although changes in these endpoints were statistically significant after 4 months, there were no differences between endpoints after 2 months, and the clinical significance is unclear.
• Necrotizing enterocolitis (NEC). It is unclear if oral Lacticaseibacillus paracasei is beneficial or safe for NEC prevention. 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). Also, guidance among regulatory agencies and clinical organizations varies with respect to the use of probiotics in very low birth weight infants under 1000 grams. The US Food and Drug Administration (FDA) warns that preterm infants given probiotics are at risk of serious infections caused by the bacteria or fungi contained in probiotics due to cases reported in this group of infants (111610). Also, The American Academy of Pediatrics does not support the routine administration of probiotics to preterm infants, particularly those with a birth weight below 1000 grams, due to conflicting data on safety and efficacy and potential for harm in this vulnerable population (111608). The Canadian Paediatric Society, the American Gastroenterological Association, and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition state that probiotic combinations may be of benefit in reducing the incidence of NEC in preterm neonates over 1000 grams. However, L. paracasei is not specifically recommended (103003,111609,111611).
• Nonalcoholic fatty liver disease (NAFLD). 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 NAFLD shows that taking 2 sachets daily for 3 months of a specific combination product (VSL#3) containing L. paracasei and other probiotics modestly decreases triglyceride levels and liver enzymes when compared with taking placebo. However, there was no change in body mass index or most glycemic or lipid parameters (111009). The effect of L. paracasei alone is unclear from this study.
• Osteoarthritis. It is unclear if oral Lacticaseibacillus paracasei is beneficial for osteoarthritis. Details: A large clinical trial in patients with mild to moderate symptoms of knee osteoarthritis shows that taking skim milk containing L. paracasei Shirota 6 billion colony-forming units twice daily for 6 months modestly improves stiffness, pain, and function when compared with taking skim milk placebo (111953). More research is needed to determine whether L. paracasei Shirota is as effective as standard medications.
• Pain (acute). It is unclear if oral Lacticaseibacillus paracasei is beneficial for acute pain. Details: Clinical research in patients with a single rib fracture shows that taking skim milk containing L. paracasei Shirota 6 billion colony-forming units daily for 1 month modestly reduces pain during deep breathing, coughing, and turning over when compared with taking skim milk placebo. Good pain relief during these situations, defined as a decline in maximal pain intensity of 3 points on a 10-point scale, occurred in 42.1% to 61.6% of patients, compared with 25.9% to 47.3% of patients taking placebo. However, there was no effect on sleep quality (111957).
• Parkinson disease. It is unclear if oral Lacticaseibacillus paracasei is beneficial for Parkinson disease. Details: Clinical research in patients with Parkinson disease shows that taking fermented milk providing L. paracasei Shirota 10 billion colony-forming units daily for 12 weeks reduces the use of laxatives by 0.37 or 15% per week and modestly improves stool consistency and symptoms of constipation when compared with taking an acidified milk placebo. There were also modest improvements in non-motor symptoms, anxiety, and depression, but not overall disease severity or dopaminergic therapy requirement (111956).
• Postoperative infection. Although there has been interest in using oral Lacticaseibacillus paracasei for preventing postoperative infections, there is insufficient reliable information about the clinical effects of L. paracasei for this purpose.
• 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.
• Proton pump inhibitor-induced gastrointestinal (GI) symptoms. It is unclear if oral Lacticaseibacillus paracasei is beneficial for preventing GI symptoms in patients using proton pump inhibitors. Details: Preliminary clinical research in patients with gastroesophageal reflux disease shows that taking L. paracasei F19 (Genefilus F19, Siffra Farmaceutici S.r.l., Italy) 24 billion colony-forming units 3 times a week for 3 or 6 months during treatment with pantoprazole 40 mg daily modestly reduces stool frequency and the severity and proportion of patients with flatulence and bloating when compared with taking placebo (111941).
• Radiation-induced 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 undergoing pelvic radiotherapy shows that taking 96 mL fermented milk (Danone) 3 times daily containing L. paracasei DN-114 001 100 million colony-forming units per gram starting one week before the initiation of radiation treatment does not delay the development of diarrhea when compared with taking a control sterilized milk product. The fermented milk was continued throughout treatment and made with the yogurt cultures Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus (112513).
• 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.
• Sarcopenia. Although there has been interest in using oral Lacticaseibacillus paracasei for sarcopenia prevention, there is insufficient reliable information about the clinical effects of L. paracasei for this purpose.
• 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.
• Small intestinal bacterial overgrowth (SIBO). It is unclear if oral Lacticaseibacillus paracasei 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. paracasei Shirota by mouth daily for 6 weeks modestly improves flatulence, but not other symptoms, when compared to baseline (91144).
• 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).
• Upper respiratory tract infection (URTI). Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children ages 3-6 years shows that taking taking fermented milk (DanActive, Dannon) containing L. paracasei DN-114 011 20 billion colony-forming units daily for 90 days reduces the incidence of URTIs by 18% when compared with taking a control non-fermented milk. The fermented milk was made with the yogurt cultures Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus (112515).
• Wound healing. It is unclear if oral Lacticaseibacillus paracasei is beneficial for the treatment of SIBO. Details: Clinical research in patients with a recent episiotomy shows that taking L. paracasei (L. casei 431) 1.5 billion colony-forming units daily for 14 days modestly improves wound severity, including redness, swelling, and discharge, 5 and 15 days after birth when compared with taking placebo. There was no effect on wound pain (112519). More evidence is needed to rate Lacticaseibacillus paracasei for these uses.

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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 in children of most ages. Bifidobacterium lactis has been safely used alone or in combination with other probiotics in infants and children 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). There is insufficient reliable information available about the safety of B. lactis in preterm infants with a birth weight under 1000 grams. Cases of bacteremia have occurred rarely in preterm infants given other probiotics (102416,111610,111612,111613,111850,111852,111853). The US Food and Drug Administration (FDA) has issued a warning about cases of serious infections caused by probiotics reported in very preterm or very low birth weight infants under 1000 grams (111610). Similarly, the American Academy of Pediatrics does not support the routine administration of probiotics to these infants due to conflicting data on safety and efficacy (111608).

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.

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LIKELY SAFE ...when live or heat-killed Lacticaseibacillus paracasei are used orally and appropriately. Live L. paracasei alone or in combination with other probiotics has been safely used in studies lasting up to 4 years (6087,14370,14371,35393,35407,103440,105133,107555,107557,110979)(111937,111938,111940,111943,111948,111950,111951,111953,111954,111955)(111958,111959,112512,112513,112518,112519). Non-viable, heat-killed L. paracasei has been safely used in studies lasting up to 3 months (111939,111940,111947). There is insufficient reliable information available about the safety of live or non-viable, heat-killed L. paracasei when used topically.

CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages. 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). L. paracasei DN-114 011 has been taken safely for 90 days in children ages 3-6 years in fermented milk (DanActive, Dannon) (112515). There is insufficient reliable information available about the safety of L. paracasei in preterm infants with a birth weight under 1000 grams. Cases of bacteremia have occurred rarely in preterm infants given other probiotics (102416,111610,111612,111613,111850,111852,111853). The US Food and Drug Administration (FDA) has issued a warning about cases of serious infections caused by probiotics reported in very preterm or very low birth weight infants under 1000 grams (111610). Similarly, the American Academy of Pediatrics does not support the routine administration of probiotics to these infants due to conflicting data on safety and efficacy (111608).

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).

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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.

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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.

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General ...Orally, Bifidobacterium lactis seems to be well tolerated by most patients.
Most Common Adverse Effects:
Orally: Diarrhea.
Serious Adverse Effects (Rare):
Orally: There is concern that probiotics may cause infections in some people.

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).

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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).
Topically, a lotion containing the cell free supernatant of L. paracasei was rarely associated with erythema, itching, and scaling (111945).

Gastrointestinal ...Orally, taking Lacticaseibacillus paracasei alone or in combination with other probiotics may cause gastrointestinal side effects including dyspepsia (105133), flatulence (107497), nausea (111952), and bloating (107497,111952); 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, meningoencephalitis, and prosthetic joint infections. 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 (107543,111942,111944,111946,90282). 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).

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