Ultimate Flora RTS Colon Care Probiotic by Renew Life

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 for NEC prevention. Details: Meta-analyses of clinical research generally show that giving various bifidobacteria species alone does NOT reduce the risk of NEC or all-cause mortality. However, only a few of the studies included in these analyses have used B. lactis (95344,95351,103437,105164). A systematic review of four studies using B. lactis shows that although NEC incidence is reduced by 89% in one study, a significant reduction was not identified in the other studies when compared with placebo (107592). More research is needed to determine the role of B. lactis in the prevention of NEC.
• Neonatal jaundice. It is unclear if oral Bifidobacterium lactis is beneficial for neonatal jaundice. Details: Clinical research in newborns with jaundice shows that taking B. lactis CP-9 5 billion colony-forming units twice daily during conventional phototherapy treatment reduces the duration of phototherapy by about 13 hours and modestly improves the decline in serum bilirubin when compared with taking placebo. A sub-analysis shows that this benefit is limited to full-term, and not preterm, newborns (110987).
• Nonalcoholic fatty liver disease (NAFLD). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In children with NAFLD, clinical research shows that taking a specific combination (Prokid, Gostaresh Milad Pouya Company) containing B. lactis DSMZ 32269 6 billion colony-forming units (CFUs), Lactobacillus acidophilus ATCC B3208 3 billion CFUs, Lacticaseibacillus rhamnosus DSMZ 21690 2 billion CFUs, and Bifidobacterium bifidum ATCC SD6576 2 billion CFUs daily for 12 weeks normalizes liver sonography findings in 53% of children, compared with 17% of those taking placebo. In addition, levels of alanine aminotransferase and aspartate aminotransferase are reduced by 30% and 25%, respectively. There was no effect on body mass index or blood lipids when compared with placebo (105156). However, other research in adults with NAFLD shows that taking probiotic yogurt 100 grams fortified with vitamin D 1000 IU plus B. lactis Bb-12 and L. acidophilus 40 million CFUs daily for 3 months does not improve fasting blood glucose levels, insulin levels, blood pressure, or anthropometric indices when compared with unfortified yogurt (105174).
• Obesity. It is unclear if oral Bifidobacterium lactis is beneficial for weight loss. Details: Clinical research in overweight and obese adults shows that taking B. lactis 420 10 billion colony-forming units (CFUs) daily for 6 months does not reduce body fat or body weight when compared with placebo (95356). However, in individuals with abdominal obesity, clinical research shows that taking B. lactis CECT 8145 (Ba8145) 10 billion CFUs for 3 months modestly decreases body mass index (BMI) when compared with placebo. Also, taking heat-killed B. lactis CECT 8145 (Ba8145) 10 billion CFUs modestly decreases waist circumference when compared with placebo. Sub-group analyses show that these benefits occur only in females, and there was no effect of these products on the visceral or subcutaneous fat areas when compared with placebo (105551). Another clinical trial shows that taking 10 billion colony-forming units each of B. lactis 420 and Lacticaseibacillus rhamnosus HN001 daily, alone and with fish oil providing eicosapentaenoic acid 0.22 grams and docosahexaenoic acid 1.9 grams (Croda Europe Ltd.), during pregnancy and for 6 months postpartum, reduces the odds of overweight at 24 months by approximately 64% or 78%, respectively, when compared with taking placebo (110336). When taken in combination with Lactobacillus acidophilus LA02, B. lactis BS01 2 billion CFUs daily for 6 weeks does not reduce body weight or body fat when compared with placebo in young, healthy individuals, only some of whom were overweight (103438). In contrast to these findings, clinical research shows that taking 50 billion CFUs of a specific combination of B. lactis, Bifidobacterium bifidum, L. acidophilus, and Lactiplantibacillus plantarum (Lab4P) for 24 weeks reduces body weight by an additional 1.3 kg more than placebo (103439). Heat-killed B. lactis has also been investigated in combination with other ingredientd. Clinical research shows that taking enriched seafood sticks 50 grams daily providing heat-inactivated B. lactis CECT 8145 5 billion colony-forming units, inulin 1.7 grams, and eicosapentaenoic acid plus docosahexaenoic acid 370 mg daily for 12 weeks does not reduce body weight, body fat, blood pressure, or most lipid or glycemic indices, when compared to taking conventional seafood sticks. There was a modest decrease in insulin levels in males (110997).
• Oropharyngeal candidiasis. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In older adults in long-term care, clinical research shows that taking a combination of B. lactis BB-12 and Lacticaseibacillus rhamnosus 13-16 billion colony-forming units daily does not reduce the incidence of oropharyngeal candidiasis when compared with placebo over a 12-month period (103425).
• Otitis media. It is unclear if oral Bifidobacterium lactis is beneficial for preventing otitis media. Details: Clinical research in one month old infants shows that taking B. lactis BB-12 10 billion colony-forming units daily for an average of about 15 months does not reduce the proportion of children with otitis media by two years of age when compared with taking placebo (95381).
• Periodontitis. It is unclear if oral Bifidobacterium lactis is beneficial for periodontitis. Details: In patients with periodontitis, a small clinical trial shows that taking B. lactis HN019 lozenges providing 1 billion colony-forming units twice daily (HOWARU1 Bifido LYO 40 DCU-S, DuPont Danisco Sweeteners Oy) for 30 days after scaling and root planing modestly improves some measures of periodontitis 60 days after treatment completion, including pocket depth and clinical attachment, when compared with using placebo lozenges. In addition, although the risk for disease progression was not improved when compared with placebo, there was a reduction in the need for additional therapy in at least three sites (105157,105158,107622).
• Postoperative bowel function. It is unclear if oral Bifidobacterium lactis is beneficial for improving postoperative bowel function. Details: Clinical research in patients undergoing colorectal polyp resection shows that taking B. lactis MH-02 2 billion colony-forming units daily for 7 days postoperatively does not reduce total postoperative gastrointestinal symptom severity when compared with taking placebo. However, the time to recovery of bowel function was reduced by about 0.7 days and there were modest improvements in defecation difficulty (110985).
• Postpartum depression. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that taking a combination of B. lactis 420 DSM 22,089 and Lacticaseibacillus rhamnosus HN001 ATCC SD5675 (Dupont Nutrition & Health) 10 billion CFUs daily, alone or with fish oil providing eicosapentaenoic acid (EPA) 0.44 grams and docosahexaenoic acid (DHA) 3.8 grams daily, does not reduce symptoms of postpartum depression or anxiety when compared with placebo. Supplements were started in the second trimester of pregnancy and continued until 6 months after delivery (107496).
• Prader-Willi syndrome (PWS). It is unclear if oral Bifidobacterium lactis is beneficial for PWS. Details: A small clinical trial in children with PWS shows that taking B. lactis BPL1 CECT8145 (Archer Daniels Midland Co-Biópolis) 10 billion colony-forming units (CFUs) daily for 12 weeks does not improve fat mass, abdominal adiposity, lipid profile, blood pressure, or glucose control when compared with placebo. However, there was a small improvement in insulin levels and measures of insulin resistance. Also, abdominal adiposity was modestly improved in a sub-group of patients over age 4.5 years, the age at which excessive weight gain typically starts in this population (105149). Other clinical research in children with PWS shows that taking B. lactis BL-11 (Beijing Huayuan Academy of Biotechnology) 30 billion CFUs twice daily for 12 weeks does not affect weight or psychological outcomes, including behavior, communication, and motor skills, when compared with placebo. However, height and overall clinical impression were modestly improved (107585).
• Pregnancy-induced nausea and vomiting. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial shows that taking probiotics during pregnancy reduces the severity and duration of nausea and vomiting by 16% to 54%. There was also a small benefit on stool hardness. A specific probiotic (Probiotics 10, Nature's Bounty) was taken as 2 capsules daily for two back-to-back cycles comprised of six days with probiotics and two days without. Each capsule contained a total of 10 billion colony-forming units (CFUs) of B. lactis Bl-04, Lactiplantibacillus plantarum 299v and DSM 15312, Lactobacillus delbrueckii subsp. bulgaricus Lb-87, Lacticaseibacillus paracasei DSM 13434 and Lpc-37, Ligilactobacillus salivarius Ls-33, Levilactobacillus brevis Lbr-35, Lactobacillus acidophilus La-14, and Lacticaseibacillus casei Lc-11, along with inulin 200 mg (107199).
• Prematurity. It is unclear if oral Bifidobacterium lactis is beneficial for preventing infections in premature infants. Details: A small clinical trial in very low birth weight premature infants shows that taking B. lactis BB-12 two billion colony-forming units per kg six times daily from birth for 6 weeks does not reduce the incidence of nosocomial infections when compared with taking placebo (110994). This study may have been too small to detect differences.
• Psoriasis. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with psoriasis shows that taking a mixture of probiotics for 8 weeks modestly improves overall disease symptoms and feelings of depression when compared with placebo. The percentage of patients achieving at least a 50% or 75% reduction in overall symptom score was 40% and 24%, respectively, compared with 16% and 8% of those taking placebo. The probiotic was taken twice daily and provided a total daily dose of 2.6 billion colony-forming units (CFUs) of B. lactis, Bifidobacterium bifidum, Bifidobacterium longum, and Lactobacillus acidophilus (107498).
• Radiation-induced diarrhea. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with cervical cancer receiving radiotherapy with or without chemotherapy shows that taking a specific product (Biogurt, Fame Pharmaceuticals) containing B. lactis BB-12 and Lactobacillus acidophilus LA-5 1.75 billion lyophilized live colony-forming units in a capsule three times daily throughout radiation treatment reduces the risk of diarrhea by 28% when compared with placebo. Taking probiotics also reduced the use of loperamide when compared with placebo (102285).
• Rheumatoid arthritis (RA). Although there has been interest in using oral Bifidobacterium lactis for RA, there is insufficient reliable information about the clinical effects of B. lactis for this condition.
• Rotaviral diarrhea. It is unclear if oral B. lactis is beneficial for rotaviral diarrhea. Details: Small clinical studies show that giving B. lactis BB-12 alone or along with Streptococcus thermophilus may help reduce the incidence of diarrhea and rotavirus shedding in infants and children up to 36 months old (3169).
• Ulcerative colitis. Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial shows that taking a specific product (Probio-Tec AB-25) containing B. lactis BB-12 and Lactobacillus acidophilus La-5 is not beneficial for preventing relapse in patients with ulcerative colitis when compared with placebo (95338).
• Urinary tract infections (UTIs). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients in adults and children; its effect when used alone is unclear. Details: In children aged 4 months to 5 years with a previous UTI, clinical research shows that taking a specific combination (Complete Probiotic Platinum) of B. lactis 750 million colony-forming units (CFUs), Bifidobacterium bifidum 200 million CFUs, Lactobacillus acidophilus 750 million CFUs, and Lacticaseibacillus rhamnosus 50 million CFUs per kg twice daily for 18 months increases the median time to the first incidence of recurrence by approximately 3 months and increases the percentage of children without a UTI during the study period from 83% to 97% (103436). However, in older adults in long-term care, taking a combination of B. lactis BB-12 and L. rhamnosus 13-16 billion CFUs daily does not reduce the incidence of UTI when compared with placebo over a 12-month period (103425).
• Ventilator-associated pneumonia (VAP). Oral Bifidobacterium lactis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that taking B. lactis BB12 1.75 billion colony-forming units (CFUs), Lactobacillus acidophilus LA-5 1.75 billion CFUs, Lactiplantibacillus plantarum 500 million CFUs, and Saccharomyces boulardii 1.5 billion CFUs twice daily for 15 days reduces the risk of VAP to 12%, compared with 28% of patients taking placebo. Half of the dose was given onto the oropharynx and half via a nasogastric tube (107524). More evidence is needed to rate Bifidobacterium lactis for these uses.

(Read more about BIFIDOBACTERIUM ANIMALIS SUBSP. LACTIS)

POSSIBLY EFFECTIVE

• Irritable bowel syndrome (IBS). Oral Bifidobacterium bifidum seems to be beneficial for reducing symptoms of IBS. Details: Clinical research shows that taking live or heat-inactivated B. bifidum MIMBb75 is beneficial for improving gastrointestinal symptoms in patients with IBS (105155,105160). Taking 1 billion colony-forming units (CFUs) daily for 4 weeks results in an overall responder rate of 57%, compared with 21% in the placebo group. There were specific improvements in abdominal pain, bloating, and urgency (105160). When taking the heat-inactivated form of B. bifidum MIMBb75 (SYN-HI-001) 1 billion cells daily for 8 weeks, 34% of patients experienced at least a 30% improvement in abdominal pain and overall relief of symptoms in at least 4 of the 8 weeks, compared with only 19% of those taking placebo (105155). A clinical study in patients with diarrhea-predominant IBS shows that taking a specific combination product (NordBiotic, MBM Biotix) containing B. bifidum BF030, Bifidobacterium breve BB010, Bifidobacterium longum BL020, Bifidobacterium animalis subsp. lactis BL040, Lacticaseibacillus rhamnosus LR110, Lacticaseibacillus paracasei LPC100, Lactobacillus acidophilus LA120, Lacticaseibacillus casei LC130, Lactiplantibacillus 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).
• Respiratory tract infections. Most clinical research shows that taking Bifidobacterium bifidum may reduce the risk of respiratory infections in otherwise healthy individuals. Details: One clinical study shows that taking B. bifidum R0071 3 billion colony-forming units (CFUs) daily for 6 weeks decreases the percentage of college students who experience at least one day of cold or flu by about 35% when compared with placebo. The number of cold or flu episodes is also decreased by 32% when compared with placebo (90272). Some studies have evaluated probiotics containing B. bifidum along with other species. One study shows that taking a specific combination (Infloran) of B. bifidum and Lactobacillus acidophilus 1 billion CFUs each twice daily for 3 months reduces the number of school-aged children who experience cold-related fever, cough, or school absence when compared with placebo (90286). In healthy children aged 3-10 years, clinical research shows that taking 12.5 billion CFUs daily of a specific combination of B. bifidum CUL20, L. acidophilus CUL21 and CUL60, and Bifidobacterium animalis subsp. lactis CUL34 (Lab4) 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).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Age-related cognitive decline. Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in healthy adults over 65 years shows that taking a total of one billion colony-forming units (CFUs) of B. bifidum BGN4 and Bifidobacterium longum BORI daily for 12 weeks modestly improves mental flexibility when compared with placebo. However, there were no benefits on cognitive function, including language, memory, or attention (110968).
• Allergic rhinitis (hay fever). Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with seasonal allergies shows that taking B. bifidum G9-1 0.15 billion colony-forming units CFUs), Bifidobacterium longum MM-2 0.15 billion CFUs, and Lactobacillus gasseri KS-13 1.2 billion CFUs twice daily for 8 weeks during allergy season modestly improves quality of life, specifically nasal symptoms, when compared with taking placebo. However, eye symptoms were not improved (110972).
• Alzheimer disease. Although there has been interest in using oral Bifidobacterium bifidum for Alzheimer disease, there is insufficient reliable information about the clinical effects of B. bifidum for this condition.
• Antibiotic-associated diarrhea. Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A large clinical trial shows that taking a total of 60 billion colony-forming units (CFUs) of B. bifidum CUL20 NCIMB 30153, Bifidobacterium lactis CUL 34 NCIMB 30172, and Lactobacillus acidophilus CUL60 NCIMB 30157 and CUL 21 NCIMB 30156 daily for 21 days does not reduce the risk of antibiotic-associated diarrhea when compared with placebo (92255). An additional large clinical trial in children aged 3 months and up shows that taking B. bifidum 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 B. bifidum W23, Bifidobacterium animalis subsp. lactis W51, Lactobacillus acidophilus W37, Lactobacillus acidophilus W55, Lacticaseibacillus paracasei W20, 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). A meta-analysis of 4 clinical trials in hospitalized or outpatient adults shows that taking B. bifidum in combination with up to 8 other probiotic strains does not reduce the risk of antibiotic-associated diarrhea when compared with placebo (107635).
• Atopic dermatitis (eczema). Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a combination of B. bifidum, Ligilactobacillus salivarius, Lacticaseibacillus paracasei, and Bifidobacterium animalis subsp. lactis during pregnancy, from approximately 35 weeks' gestation until birth, and then giving this same 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% when compared with placebo (90234).
• Bacterial vaginosis. Although there has been interest in using oral Bifidobacterium bifidum for bacterial vaginosis, there is insufficient reliable information about the clinical effects of B. bifidum for this condition.
• Cancer. Although there has been interest in using oral Bifidobacterium bifidum for cancer prevention or treatment, there is insufficient reliable information about the clinical effects of B. bifidum for this condition.
• Clostridioides difficile infection. It is unclear if oral Bifidobacterium bifidum is beneficial for preventing C. difficile infection. Details: Preliminary clinical research in patients undergoing elective colon cancer surgery shows that taking B. bifidum does not prevent C. difficile infection when compared with taking no additional treatment. All patients received a single intravenous dose of antibiotics before surgery. B. bifidum (Biofermin) provided 10 billion colony-forming units daily for 7 days before surgery and for 10 days after surgery starting on postoperative day 5 (110982). B. bifidum has also been investigated in combination with other probiotics. A large clinical study in hospitalized adults aged 65 years or older shows that taking a combination of B. bifidum, Bifidobacterium animalis subsp. lactis, and Lactobacillus acidophilus as 60 billion colony-forming units (CFUs) daily for 21 days does not reduce the incidence of C. difficile diarrhea when compared with placebo (92255). Also, taking B. bifidum and L. acidophilus is not beneficial for reducing the incidence of C. difficile diarrhea when compared with placebo (95364). However, one small clinical study shows that taking B. bifidum along with L. acidophilus, Lactobacillus delbrueckii subsp. bulgaricus, and Streptococcus thermophilus as 12 billion CFUs total daily, starting 1 day after beginning antibiotic treatment, reduces the risk of C. difficile diarrhea by about 72% in adult inpatients (95364).
• Colic. Although there has been interest in using oral Bifidobacterium bifidum for colic, there is insufficient reliable information about the clinical effects of B. bifidum for this condition.
• Common cold. Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in healthy adults shows that taking B. bifidum, in combination with other probiotics and vitamins/minerals, daily for at least 3 months reduces the duration of common cold episodes by approximately 2 days when compared with taking a placebo providing only the vitamins/minerals. However, there was no difference in the number of common cold episodes. The probiotic supplement provided B. bifidum MF 20/5 5 million colony-forming units (CFUs), Bifidobacterium longum SP 07/3 5 million CFUs, and Lactobacillus gasseri PA 16/8 40 million CFUs (Tribion Harmonis) daily (110978).
• Constipation. It is unclear if oral Bifidobacterium bifidum is beneficial for constipation. Details: Clinical research shows that taking B. bifidum CCFM16 (Jiangsu WECARE-Probiotics Biotechnology Co., Ltd) 2 billion colony-forming units (CFUs) daily for 28 days does not improve patient-described symptoms of constipation or increase the number of weekly spontaneous bowel movements when compared with placebo. However, 42% of patients taking B. bifidum had at least 3 spontaneous bowel movements weekly, compared with 12% of those taking placebo. Stool consistency was also improved (107579). B. bifidum has also been investigated in combination with other probiotics and ingredients in clinical research in adults with chronic constipation. One study shows that taking B. bifidum in combination with Bifidobacterium longum, B. longum subsp. infantis, Lactobacillus acidophilus, Lacticaseibacillus casei, and Lactobacillus delbrueckii subsp. lactis (Hexbio) as 30 billion CFUs twice daily for 7 days increases the number of weekly bowel movements by about 2 when compared with placebo (90266). Another study shows that taking B. bifidum UABb-10 300 million CFUs daily for 4 weeks in combination with Bifidobacterium longum UABl-14 300 million CFUs, Bifidobacterium animalis subsp. lactis UABla-12 7.8 billion CFUs, Lactobacillus acidophilus DDS-1 6.6 billion CFUs, and fructo-oligosaccharides (FOS) 7 mg does not improve symptoms of constipation when compared with a placebo providing FOS (110970).
• Dental plaque. It is unclear if oral Bifidobacterium bifidum is beneficial for dental plaque. Details: A small clinical study in children ages 8-10 years shows that eating 110 grams of probiotic fruit yogurt (Activia Çilekli Meyveli, Danone) containing B. bifidum DN-173 010 1.1 trillion colony-forming units daily for 2 weeks does not reduce dental plaque when compared with a placebo fruit yogurt (102410). This study was limited by small size and the use of a sweet yogurt, which might increase dental plaque.
• Depression. Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in patients with major depression shows that taking Bifidobacterium bifidum, Lacticaseibacillus casei, and Lactobacillus acidophilus daily for 8 weeks reduces symptoms of depression measured on the Beck Depression Inventory (BDI) when compared with placebo (99780). However, the validity of the results from this study is limited by incomplete reporting. For example, patient baseline BDI scores were not reported.
• Diabetes. It is unclear if oral Bifidobacterium bifidum is beneficial for diabetes. Details: Clinical research in patients with gestational diabetes shows that taking freeze-dried B. bifidum, Lactobacillus acidophilus, and Lacticaseibacillus casei, each as 2 billion colony-forming units (CFUs) per gram daily for 6 weeks, decreases fasting plasma glucose levels by 5-9 mg/dL and reduces insulin resistance and insulin levels when compared with placebo (95416,98430). In contrast, a large clinical trial shows that taking B. bifidum sp9 cs at least 6 billion CFUs, L. acidophilus LA1 at least 7.5 billion CFUs, and Bifidobacterium longum sp54 cs at least 1.5 billion CFUs daily from 14-24 weeks' gestation does not reduce the incidence of gestational diabetes when compared with taking placebo (107520). Limited evidence has also assessed the effects of B. bifidum for type 2 diabetes. A small clinical trial in patients taking metformin shows that taking B. bifidum G9-1 (Biofermin) 72 mg three times daily for 10 weeks modestly improves symptoms of diarrhea and constipation when compared with baseline. However, there was no effect on levels of fasting blood glucose or glycated hemoglobin (110975). A small clinical study shows that taking a combination of B. bifidum, L. acidophilus, and Streptococcus thermophilus daily for 12 weeks does not reduce levels of fasting blood glucose or glycated hemoglobin when compared with placebo (107521).
• Diabetic nephropathy. Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with diabetic nephropathy who are not taking antidiabetes drugs shows that taking a combination of B. bifidum, Lactobacillus acidophilus, and Streptococcus thermophilus daily for 12 weeks modestly reduces the ratio of microalbuminuria/creatinine (mAlb/Cr), a marker of kidney damage, when compared with placebo. However, there was no effect on the estimated glomerular filtration rate (eGFR) (107521).
• Diarrhea. It is unclear if oral Bifidobacterium bifidum is beneficial for 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. bifidum is not a specific focus of the guidelines and most evidence on the use of this species is low quality.
• Exercise-induced respiratory infections. Although there has been interest in using oral Bifidobacterium bifidum for preventing exercise-induced respiratory infections, there is insufficient reliable information about the clinical effects of B. bifidum for this use.
• Familial hypercholesterolemia. It is unclear if oral B. bifidum is beneficial for familial hypercholesterolemia. Details: Preliminary clinical research in children 6-18 years of age with high cholesterol shows that taking a probiotic containing B. bifidum MB 109, Bifidobacterium animalis subsp. lactis MB 2409, and Bifidobacterium longum BL04 daily for 12 weeks reduces total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglyceride levels by 2% to 3% and increases HDL cholesterol levels by about 2% when compared with placebo. However, these changes might not be considered clinically significant (98736).
• Generalized anxiety disorder (GAD). Oral Bifidobacterium bifidum 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. bifidum, Bifidobacterium longum, Bifidobacterium animalis subsp. lactis, and Lactobacillus acidophilus (110977).
• Helicobacter pylori. Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One preliminary clinical trial in children with symptomatic H. pylori infection shows that taking a combination probiotic containing B. bifidum and Lactobacillus acidophilus daily for 6 weeks, in conjunction with triple therapy, increases the H. pylori eradication rate by an additional 19% when compared with triple therapy alone (90602). However, other individual clinical trials have shown that taking B. bifidum, L. acidophilus, Lacticaseibacillus rhamnosus, and Streptococcus faecium may not improve eradication rates when taken with triple therapy consisting of furazolidone, tetracycline, and lansoprazole (90279).
• HIV/AIDS. Although there has been interest in using oral Bifidobacterium bifidum for HIV/AIDS, there is insufficient reliable information about the clinical effects of B. bifidum for this condition.
• Hyperlipidemia. Although there has been interest in using oral Bifidobacterium bifidum for hyperlipidemia, there is insufficient reliable information about the clinical effects of B. bifidum for this condition.
• Necrotizing enterocolitis (NEC). It is unclear if oral Bifidobacterium bifidum is beneficial for NEC prevention. Details: Meta-analyses of clinical research generally show that giving various bifidobacteria species alone does NOT reduce the risk of NEC or all-cause mortality (95344,95351,103437,105164). However, giving bifidobacteria in combination with lactobacilli or Enterococcus faecalis to preterm infants appears to reduce the risk of NEC and giving bifidobacteria with a prebiotic appears to reduce the risk of mortality (3162,90252,95351,102419,103437,103448,104157,105162,105164). The effects of B. bifidum, specifically, are unclear. More research is needed to determine the role of B. bifidum in the prevention of NEC.
• Nonalcoholic fatty liver disease (NAFLD). Oral Bifidobacterium bifidum 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) of B. bifidum ATCC SD6576 2 billion colon-forming units (CFUs), Lactobacillus acidophilus ATCC B3208 3 billion CFUs, Lacticaseibacillus rhamnosus DSMZ 21690 2 billion CFUs, and Bifidobacterium animalis subsp. lactis DSMZ 32269 6 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 decreased by 30% and 25%, respectively. There was no effect on body mass index or blood lipids when compared with placebo (105156). However, a small clinical trial in adults shows that taking a combination of B. bifidum BMCM 02290, Bifidobacterium longum BCMC 02129, B. longum BCMC 02120, Lactobacillus acidophilus BCMC 12,130, Lacticaseibacillus casei BCMC 12,313, and Lactobacillus delbrueckii subsp. lactis BCMC 12,451 as 30 billion CFUs twice daily for 6 months has no beneficial effects on hepatic steatosis or fibrosis, liver enzyme levels, blood lipids, or fasting blood glucose levels when compared with placebo (107523).
• Nonalcoholic steatohepatitis (NASH). Although there has been interest in using oral Bifidobacterium bifidum for NASH, there is insufficient reliable information about the clinical effects of B. bifidum for this condition.
• Obesity. Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that taking 50 billion CFUs of a specific combination of B. bifidum, Bifidobacterium animalis subsp. lactis, Lactobacillus acidophilus, and Lactiplantibacillus plantarum (Lab4P) for 24 weeks reduces body weight by an additional 1.3 kg more than placebo (103439).
• Oropharyngeal candidiasis. Although there has been interest in using oral Bifidobacterium bifidum for oropharyngeal candidiasis, there is insufficient reliable information about the clinical effects of B. bifidum for this condition.
• Pharyngitis. Although there has been interest in using oral Bifidobacterium bifidum for pharyngitis prevention, there is insufficient reliable information about the clinical effects of B. bifidum for this condition.
• Polycystic ovary syndrome (PCOS). Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In patients with PCOS, clinical research shows that taking a combination of B. bifidum T1 (IBRC-M10771), Lactobacillus acidophilus T16 (IBRC-M10785), and Lacticaseibacillus casei T2 (IBRC-M10783) 2 billion colony-forming units each, plus inulin 800 mg, daily for 12 weeks modestly reduces serum insulin and triglyceride levels and improves insulin resistance and insulin sensitivity when compared with placebo. There was no effect on levels of cholesterol or fasting glucose (105159). Another clinical trial shows that 31.3% of patients with PCOS taking B. bifidum in combination with other probiotics daily for 6 months had regular menstrual cycles compared with 12.5% of those taking placebo. There were also modest improvements in testosterone levels and waist circumference, but not other hormones, insulin resistance, body weight, or most measures of quality of life. The product provided B. bifidum UBBB-55, Lactiplantibacillus plantarum UBLP-40, Lacticaseibacillus casei UBLC-42, and Limosilactobacillus fermentum UBLF-31, one billion colony-forming units (CFUs) each, as well as Lactobacillus acidophilus UBLA-34, Lacticaseibacillus rhamnosus UBLR-58, Limosilactobacillus reuteri UBLRu-87, 2 billion CFUs each, and fructo-oligosaccharides (FOS) 100 mg daily for 2 months and then twice daily for 4 months. All patients also underwent dietary and lifestyle changes (110974).
• Postoperative infection. It is unclear if oral Bifidobacterium bifidum is beneficial for preventing postoperative infection. Details: Preliminary clinical research in patients undergoing elective colon cancer surgery shows that taking B. bifidum does not prevent surgical site or other infection or leakage when compared with taking no additional treatment. All patients received a single intravenous dose of antibiotics before surgery. B. bifidum (Biofermin) provided 10 billion colony-forming units daily for 7 days before surgery and for 10 days after surgery starting on postoperative day 5 (110982).
• Pouchitis. Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study shows that taking a specific product (Trilac, Allergon AB) containing B. bifidum 600 million colony-forming units (CFUs), Lactobacillus acidophilus 600 million CFUs, and Lactobacillus delbrueckii subsp. bulgaricus 400 million CFUs per capsule, taken in doses of 2 capsules three times daily for 9 months, can reduce pouchitis severity and the number of patients experiencing pouchitis when compared to baseline (90296).The validity of these findings is limited by the lack of a comparator group.
• Prematurity. It is unclear if oral Bifidobacterium bifidum is beneficial for growth and development of premature infants. Details: Clinical research in very low birthweight premature infants shows that taking B. bifidum OLB6378 2.5 billion colony-forming units (CFUs) in two divided doses daily until body weight reached 2000 grams or 4.4 pounds reduces the time to established enteral feeding by 1.1 days when compared with taking placebo. There was no effect on other outcomes, including growth, length of hospital stay, mortality, or morbidities (110971).
• Psoriasis. Oral B. bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with psoriasis shows that taking a mixture of probiotics for 8 weeks modestly improves overall symptoms and feelings of depression when compared with placebo. The percentage of patients achieving at least a 50% or 75% reduction in overall symptom score was 40% and 24%, respectively, in those taking the probiotic mixture, compared with 16% and 8% of those taking placebo. Each probiotic capsule was used twice daily and provided a total daily dose of 2.6 billion colony-forming units (CFUs) of B. bifidum, Bifidobacterium animalis subsp. lactis, Bifidobacteruim longum, and Lactobacillus acidophilus (107498).
• Radiation-induced diarrhea. Oral Bifidobacterium bifidum 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 with weekly cisplatin shows that taking B. bifidum (Infloran) and Lactobacillus acidophilus as 1 billion colony-forming units (CFUs) each twice daily, from seven days before starting radiotherapy and continuing during radiotherapy, reduces the incidence of moderate to severe diarrhea and the need for antidiarrheal medication when compared with placebo. Moderate to severe diarrhea occurred in 9% of patients taking probiotics, compared with 45% of those taking placebo (107580).
• Rheumatoid arthritis (RA). Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study in patients with moderate-to-severe RA shows that taking capsules containing freeze-dried strains of B. bifidum, Lactobacillus acidophilus, and Lacticaseibacillus casei daily for 8 weeks does not reduce RA severity, the number of tender or swollen joints, or joint pain when compared with placebo (95418).
• Ulcerative colitis. Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Some preliminary clinical research shows that taking a fermented milk (Yakult, Yakult Honsha Co., Ltd.) containing B. bifidum, Bifidobacterium breve, and Lactobacillus acidophilus as an adjunct to standard maintenance therapy might help prevent relapse in ulcerative colitis patients when compared with a control group (12775,14338). Preliminary clinical research in patients with moderate to severe symptoms taking mesalazine 1200 mg daily shows that taking an unknown dose of B. bifidum BGN4 twice daily along with Lactobacillus acidophilus and Ligilactobacillus salivarius (Acronelle, Bromatech srl, Milan, Italy) for 2 years modestly improves patient- and physician-scales of overall symptoms when compared with taking mesalazine alone. There were also improvements in stool frequency and rectal bleeding (110981).
• Urinary tract infections (UTIs). Oral Bifidobacterium bifidum has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In children aged 4 months to 5 years with a previous UTI, clinical research shows that taking a specific combination (Complete Probiotic Platinum) of B. bifidum 200 million colony-forming units (CFUs), Bifidobacterium animalis subsp. lactis 750 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% when compared with placebo (103436). More evidence is needed to rate Bifidobacterium bifidum for these uses.

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POSSIBLY INEFFECTIVE

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

INSUFFICIENT RELIABLE EVIDENCE to RATE

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

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

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

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LIKELY SAFE ...when used orally and appropriately. Bifidobacterium bifidum has been safely used alone or in combination with other probiotics in clinical trials lasting up to one year (1731,12775,14338,92255,107580,110972,110974,110978). There is insufficient reliable information available about the safety of non-viable, heat-killed B. bifidum formulations when used orally.

CHILDREN: LIKELY SAFE
when used orally and appropriately. Bifidobacterium bifidum has been safely used alone or in combination with other probiotics in clinical trials in children of all ages for up to 18 months (161,90286,90602,98736,103436,110971,110976,110924).

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

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

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

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

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

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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 = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking Bifidobacterium. bifidum with antibiotic drugs might decrease the effectiveness of B. bifidum.  Details Since B. bifidum 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. bifidum preparations by at least 2 hours.

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

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

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

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

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

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General ...Orally, Bifidobacterium bifidum seems to be well tolerated by most patients.

Gastrointestinal ...Bloating and flatulence have been reported with probiotic use; however, these adverse effects have not been reported from ingestion of Bifidobacterium bifidum in particular. One case of vomiting and fever has been reported in a clinical study for a single child taking B. bifidum and Lactobacillus acidophilus. It is unclear if the probiotics were the causal agent (90286).

Immunologic ...There have been cases of Bifidobacterium sepsis in critically ill patients (102416,107599). However, these cases are rare and none seem to be due to Bifidobacterium bifidum.

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

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

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

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