Research

Bifidobacterium breve

38 peer-reviewed studies curated from PubMed and Semantic Scholar.

0
Meta-analyses
0
Systematic reviews
36
RCTs
2
Other studies
RCTs (95%)
Observational (3%)

Studies

Sorted by quality and recency

2025·European journal of clinical nutrition·Ying Wang, Harm Wopereis, Alexia Kakourou, et al

Restoration of gut microbiota with a specific synbiotic-containing infant formula in healthy Chinese infants born by cesarean section.

RCTn = 224Gut Health

RCT investigating the effect of a synbiotic mixture containing Bifidobacterium breve and scGOS/lcFOS on gut microbiota development in C-section and vaginally-born infants. The synbiotic enhanced bifidobacterial species diversity and restored gut colonizers in C-section born infants, with effects observed beyond the intervention period.

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2022·Journal of Immunology Research·L. Drago, Luigi Cioffi, M. Giuliano, et al

The Probiotics in Pediatric Asthma Management (PROPAM) Study in the Primary Care Setting: A Randomized, Controlled, Double-Blind Trial with Ligilactobacillus salivarius LS01 (DSM 22775) and Bifidobacterium breve B632 (DSM 24706)

RCTn = 422Immunity

The PROPAM study was a randomized, placebo-controlled, double-blind trial involving 422 children to assess the effect of a probiotic mixture containing Ligilactobacillus salivarius LS01 and Bifidobacterium breve B632 on asthma exacerbations. The probiotic significantly reduced the number of asthmatic exacerbations, demonstrating safety and efficacy as an auxiliary remedy in pediatric asthma management.

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2020·Clinical nutrition (Edinburgh, Scotland)·Laurent Béghin, Sebastian Tims, Mieke Roelofs, et al

Fermented infant formula (with Bifidobacterium breve C50 and Streptococcus thermophilus O65) with prebiotic oligosaccharides is safe and modulates the gut microbiota towards a microbiota closer to that of breastfed infants.

RCTn = 280Gut Health Immunity

RCT investigating the effect of a fermented infant formula containing Bifidobacterium breve, Streptococcus thermophilus, and prebiotics on gut microbiota and SIgA levels in infants. The formula improved SIgA levels and microbiota composition towards that of breastfed infants, indicating positive effects on gut health and immunity.

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2016·Health technology assessment (Winchester, England)·Kate Costeloe, Ursula Bowler, Peter Brocklehurst, et al

A randomised controlled trial of the probiotic Bifidobacterium breve BBG-001 in preterm babies to prevent sepsis, necrotising enterocolitis and death: the Probiotics in Preterm infantS (PiPS) trial.

RCTn = 1,310

This double-blind, randomised, placebo-controlled trial tested the probiotic Bifidobacterium breve BBG-001 in preterm babies to prevent necrotising enterocolitis, late-onset sepsis, and death. The study included 1310 babies and found no evidence of benefit for the primary outcomes, with similar rates of sepsis, NEC, and death between the probiotic and placebo groups.

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2025·Clinical nutrition (Edinburgh, Scotland)·Yao Dong, Yihui Cai, Hairui Tian, et al

The impact of Bifidobacterium breve BBr60 (BBr60) on metabolic and gastrointestinal health in healthy adults: A combined in vitro metabolomic and randomized, double-blind, placebo-controlled study.

RCTn = 109Gut Health Mental Clarity Heart Health

This study evaluated the effects of Bifidobacterium breve BBr60 on metabolic and gastrointestinal health in 109 healthy adults over 8 weeks. The BBr60 group showed significant improvements in HDL levels, reductions in total cholesterol, and enhanced gastrointestinal health. Neuropsychiatric symptoms related to alcohol consumption were alleviated, and emotional states improved, with increased positive emotional scores and decreased negative scores.

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2023·American journal of obstetrics & gynecology MFM·Rebecca L Moore, Conor Feehily, Sarah Louise Killeen, et al

Ability of Bifidobacterium breve 702258 to transfer from mother to infant: the MicrobeMom randomized controlled trial.

RCTn = 160Gut Health

This double-blinded, placebo-controlled RCT investigated if maternal supplementation of Bifidobacterium breve 702258 from early pregnancy until 3 months postpartum could transfer to the infant gut. The presence of the supplemented strain was detected in 2 infants in the intervention group and none in the control group, indicating infrequent direct mother-to-infant strain transfer.

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2022·Journal of Alzheimer's disease : JAD·Daisuke Asaoka, Jinzhong Xiao, Tsutomu Takeda, et al

Effect of Probiotic Bifidobacterium breve in Improving Cognitive Function and Preventing Brain Atrophy in Older Patients with Suspected Mild Cognitive Impairment: Results of a 24-Week Randomized, Double-Blind, Placebo-Controlled Trial.

RCTn = 115Brain Health Mental Clarity

RCT of 130 older patients with suspected mild cognitive impairment comparing Bifidobacterium breve MCC1274 to placebo for 24 weeks. Cognitive function improved on some subscales, and probiotic supplementation tended to suppress brain atrophy progression, particularly in subjects with progressed brain atrophy.

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2021·Clinical nutrition (Edinburgh, Scotland)·Arianna Solito, Nicole Bozzi Cionci, Matteo Calgaro, et al

Supplementation with Bifidobacterium breve BR03 and B632 strains improved insulin sensitivity in children and adolescents with obesity in a cross-over, randomized double-blind placebo-controlled trial.

RCTn = 101Nutrition

Cross-over, double-blind, randomized control trial assessing the impact of Bifidobacterium breve BR03 and B632 supplementation on insulin sensitivity in 101 youths with obesity. Probiotics improved insulin sensitivity at fasting and during OGTT, with no adverse events reported.

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2020·Pediatric research·Paul Fleming, Mark Wilks, Simon Eaton, et al

Bifidobacterium breve BBG-001 and intestinal barrier function in preterm babies: Exploratory Studies from the PiPS Trial.

RCTn = 94Gut Health -

RCT of Bifidobacterium breve BBG-001 in 94 preterm babies assessing intestinal permeability, stool microbiota, SCFAs, and mucosal inflammation. The trial found no evidence of efficacy in reducing necrotising enterocolitis or modifying intestinal barrier function.

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2020·Journal of Alzheimer's disease : JAD·Jinzhong Xiao, Noriko Katsumata, Francois Bernier, et al

Probiotic Bifidobacterium breve in Improving Cognitive Functions of Older Adults with Suspected Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled Trial.

RCTn = 80Brain Health

RCT of 80 healthy older adults with suspected MCI testing Bifidobacterium breve A1 (MCC1274) versus placebo for 16 weeks. The probiotic group showed significant improvements in cognitive functions, particularly in immediate memory, visuospatial/constructional, and delayed memory, with no adverse events reported.

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2010·The American journal of clinical nutrition·Taciana Duque Braga, Giselia Alves Pontes da Silva, Pedro Israel Cabral de Lira, et al

Efficacy of Bifidobacterium breve and Lactobacillus casei oral supplementation on necrotizing enterocolitis in very-low-birth-weight preterm infants: a double-blind, randomized, controlled trial.

RCTn = 231Gut Health

A double-blind, randomized, controlled trial in 231 very-low-birth-weight preterm infants assessed the efficacy of Bifidobacterium breve and Lactobacillus casei supplementation in preventing necrotizing enterocolitis (NEC). The intervention group showed a reduction in NEC occurrence compared to the control group, suggesting improved intestinal motility contributed to the positive outcome.

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2004·Journal of pediatric gastroenterology and nutrition·H Thibault, C Aubert-Jacquin, O Goulet

Effects of long-term consumption of a fermented infant formula (with Bifidobacterium breve c50 and Streptococcus thermophilus 065) on acute diarrhea in healthy infants.

RCTn = 971Gut Health

RCT of 971 infants aged 4 to 6 months comparing fermented infant formula with Bifidobacterium breve C50 and Streptococcus thermophilus 065 to standard formula over 5 months. The fermented formula reduced the severity of acute diarrhea, with fewer cases of dehydration, medical consultations, ORS prescriptions, and formula switches.

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2023·Alimentary pharmacology & therapeutics·Nina Løn, Sara Engel, Anders Damholt, et al

Bifidobacterium breve Bif195 ameliorates aspirin-induced gastric mucosal damage: A randomised, double blind, placebo-controlled crossover trial.

RCTn = 25Gut Health

A randomised, double-blind, placebo-controlled crossover trial with 25 healthy volunteers evaluated the effect of Bifidobacterium breve Bif195 on aspirin-induced gastric mucosal damage. Bif195 significantly reduced gastric Lanza scores compared to placebo, indicating a protective effect against aspirin-induced gastric damage.

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2021·Brain, behavior, and immunity·Peijun Tian, Ying Chen, Huiyue Zhu, et al

Bifidobacterium breve CCFM1025 attenuates major depression disorder via regulating gut microbiome and tryptophan metabolism: A randomized clinical trial.

RCTn = 45Mood Gut Health

RCT assessing Bifidobacterium breve CCFM1025 in 45 patients with major depression disorder. The probiotic showed a better antidepressant-like effect than placebo, improving mood and gastrointestinal symptoms. Mechanisms may involve changes in gut microbiome and tryptophan metabolism.

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2019·Gastroenterology·Brynjulf Mortensen, Clodagh Murphy, John O'Grady, et al

Bifidobacteriumbreve Bif195 Protects Against Small-Intestinal Damage Caused by Acetylsalicylic Acid in Healthy Volunteers.

RCTn = 75Gut Health

RCT of 75 healthy volunteers assessing the efficacy of Bifidobacterium breve (Bif195) in reducing small-intestinal damage caused by acetylsalicylic acid (ASA). The Bif195 group showed significantly lower AUC for intestinal damage and ulcer number compared to placebo, indicating a protective effect against ASA-induced enteropathy.

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2018·Critical care (London, England)·Kentaro Shimizu, Tomoki Yamada, Hiroshi Ogura, et al

Synbiotics modulate gut microbiota and reduce enteritis and ventilator-associated pneumonia in patients with sepsis: a randomized controlled trial.

RCTn = 72Gut Health Immunity

RCT of 72 sepsis patients in ICU comparing synbiotics to no synbiotics. Synbiotics group had significantly lower incidence of enteritis and ventilator-associated pneumonia. Fecal Bifidobacterium and Lactobacillus counts and organic acid concentrations were higher in the synbiotics group.

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2017·Pediatric research·David C A Candy, Marleen T J Van Ampting, Manon M Oude Nijhuis, et al

A synbiotic-containing amino-acid-based formula improves gut microbiota in non-IgE-mediated allergic infants.

RCTn = 71Gut Health

This multicenter, double-blind, randomized controlled trial investigated the effects of an amino-acid-based formula including a synbiotic blend on gut microbiota in infants with suspected non-IgE-mediated cow's milk allergy. The test formula, containing fructo-oligosaccharides and Bifidobacterium breve M-16V, improved bifidobacteria levels and reduced ER/CC levels compared to the control formula without synbiotics.

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2016·Journal of clinical gastroenterology·Enza Giglione, Flavia Prodam, Simonetta Bellone, et al

The Association of Bifidobacterium breve BR03 and B632 is Effective to Prevent Colics in Bottle-fed Infants: A Pilot, Controlled, Randomized, and Double-Blind Study.

RCTn = 60

Pilot RCT assessing the effectiveness of Bifidobacterium breve BR03 and B632 in reducing crying in bottle-fed infants with colics. No significant differences were found overall, but during the third month, the probiotic group cried significantly less than the placebo group.

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2016·Journal of pediatric gastroenterology and nutrition·Tadaharu Okazaki, Takashi Asahara, Atsuyuki Yamataka, et al

Intestinal Microbiota in Pediatric Surgical Cases Administered Bifidobacterium Breve: A Randomized Controlled Trial.

RCTGut Health Immunity

RCT examining the effects of orally administered Bifidobacterium breve strain Yakult (BBG-01) on pediatric surgical cases. BBG-01 was well tolerated and significantly decreased postoperative infectious complications. Fecal analysis showed increased Bifidobacterium and decreased harmful bacteria, with improved intestinal environment and reduced bacterial translocation.

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2014·PloS one·Sanjay Patole, Anthony D Keil, Annie Chang, et al

Effect of Bifidobacterium breve M-16V supplementation on fecal bifidobacteria in preterm neonates--a randomised double blind placebo controlled trial.

RCTn = 159Gut Health

RCT assessing Bifidobacterium breve M-16V supplementation in preterm neonates. The probiotic group showed a significant increase in fecal B. breve counts compared to placebo, with no adverse effects or deaths. B. breve M-16V is deemed suitable for routine use in this population.

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2011·The British journal of nutrition·Florence Campeotto, Antonia Suau, Nathalie Kapel, et al

A fermented formula in pre-term infants: clinical tolerance, gut microbiota, down-regulation of faecal calprotectin and up-regulation of faecal secretory IgA.

RCTn = 58Gut Health Immunity

RCT evaluating a fermented pre-term infant formula containing Bifidobacterium breve and Streptococcus thermophilus. The formula was well tolerated, reduced faecal calprotectin, and increased secretory IgA, indicating benefits on inflammatory and immune markers.

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2010·European journal of clinical nutrition·M Morisset, C Aubert-Jacquin, P Soulaines, et al

A non-hydrolyzed, fermented milk formula reduces digestive and respiratory events in infants at high risk of allergy.

RCTn = 129Gut Health Immunity

This multicenter, randomized, double-blind, controlled study evaluated the impact of a non-hydrolyzed fermented infant formula containing heat-killed Bifidobacterium breve and Streptococcus thermophilus on allergy-like events in infants at high risk of atopy. The formula reduced the incidence of digestive and respiratory potentially allergic adverse events compared to standard infant formula.

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2010·Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology·L B van der Aa, H S Heymans, W M van Aalderen, et al

Effect of a new synbiotic mixture on atopic dermatitis in infants: a randomized-controlled trial.

RCTn = 90Gut Health Skin Hair Health

RCT of 90 infants with atopic dermatitis comparing a synbiotic mixture containing Bifidobacterium breve and a galacto-/fructooligosaccharide mixture to placebo. No overall improvement in AD severity was observed, but the synbiotic group showed significant modulation of intestinal microbiota. In infants with IgE-associated AD, the synbiotic group showed greater improvement in SCORAD score.

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2010·American journal of surgery·Susumu Eguchi, Mitsuhisa Takatsuki, Masaaki Hidaka, et al

Perioperative synbiotic treatment to prevent infectious complications in patients after elective living donor liver transplantation: a prospective randomized study.

RCTn = 50Immunity

Prospective randomized study of 50 adult patients undergoing elective living-donor liver transplantation. Patients received perioperative synbiotic therapy with Bifidobacterium breve, Lactobacillus casei, and galactooligosaccharides. The BLO group had significantly fewer infectious complications compared to the control group.

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2007·Pediatric research·Flavia Indrio, Grazia Ladisa, Angela Mautone, et al

Effect of a fermented formula on thymus size and stool pH in healthy term infants.

RCTn = 90

RCT investigating the effects of fermented formula with Bifidobacterium breve C50 and Streptococcus thermophilus 065 on thymus size and stool pH in 90 healthy term infants. The fecal pH of the FF group was similar to the breast-fed group and lower than the standard formula group. The FF infants showed a thymus index similar to breast-fed newborns, suggesting probiotic fermentation products may support immune responses.

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2004·Pediatrics international : official journal of the Japan Pediatric Society·Yudong Li, Toshiaki Shimizu, Atsuto Hosaka, et al

Effects of bifidobacterium breve supplementation on intestinal flora of low birth weight infants.

RCTGut Health

Controlled trial studying the effects of Bifidobacterium breve supplementation on low birth weight infants. Early administration of B. breve promoted the colonization of Bifidobacterium and formation of normal intestinal flora, with group A showing earlier colonization and lower Enterobacteriaceae levels compared to group B and the control group.

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2018·Clinical nutrition (Edinburgh, Scotland)·Maša Primec, Martina Klemenak, Diana Di Gioia, et al

Clinical intervention using Bifidobacterium strains in celiac disease children reveals novel microbial modulators of TNF-α and short-chain fatty acids.

RCTn = 40Gut Health Inflammation

Double-blind placebo-controlled study of 40 children with celiac disease and 16 healthy children, examining the effects of Bifidobacterium breve strains on gut microbiota, TNF-α, and short-chain fatty acids. Probiotic administration showed correlations with microbiome changes and potential anti-inflammatory effects.

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2017·Journal of pediatric gastroenterology and nutrition·Mei Chin Chua, Kaouther Ben-Amor, Christophe Lay, et al

Effect of Synbiotic on the Gut Microbiota of Cesarean Delivered Infants: A Randomized, Double-blind, Multicenter Study.

RCTn = 30Gut Health

RCT assessing the effect of synbiotic supplementation with scGOS, lcFOS, and Bifidobacterium breve M-16V on the gut microbiota of cesarean-born infants. Synbiotic supplementation increased bifidobacteria proportion and reduced Enterobacteriaceae, with lower fecal pH and higher acetate, supporting early modulation of gut microbiota similar to vaginally delivered infants.

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2016·Nutrients·Andrea Quagliariello, Irene Aloisio, Nicole Bozzi Cionci, et al

Effect of Bifidobacterium breve on the Intestinal Microbiota of Coeliac Children on a Gluten Free Diet: A Pilot Study.

RCTn = 40Gut Health

Pilot study evaluating the effect of Bifidobacterium breve supplementation on the intestinal microbiota of coeliac children on a gluten-free diet. The probiotic administration for three months increased Bifidobacterium levels and helped restore the healthy microbial balance.

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2015·Digestive diseases and sciences·Martina Klemenak, Jernej Dolinšek, Tomaž Langerholc, et al

Administration of Bifidobacterium breve Decreases the Production of TNF-α in Children with Celiac Disease.

RCTn = 49Gut Health Inflammation

Double-blinded, placebo-controlled trial of Bifidobacterium breve strains BR03 and B632 in 49 children with celiac disease on a gluten-free diet. The probiotic intervention significantly decreased TNF-α levels, indicating a positive effect on inflammation.

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2014·Journal of clinical gastroenterology·Luca Mogna, Mario Del Piano, Giovanni Mogna

Capability of the two microorganisms Bifidobacterium breve B632 and Bifidobacterium breve BR03 to colonize the intestinal microbiota of children.

RCTn = 10Gut Health

RCT assessing the capability of Bifidobacterium breve B632 and Bifidobacterium breve BR03 to colonize the intestinal microbiota of children. After 21 days of supplementation, there was a significant increase in total fecal bifidobacteria and a decrease in total coliforms, suggesting effective gut colonization and potential use in colicky infants.

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2011·Digestion·Hideki Ishikawa, Satoshi Matsumoto, Yuji Ohashi, et al

Beneficial effects of probiotic bifidobacterium and galacto-oligosaccharide in patients with ulcerative colitis: a randomized controlled study.

RCTn = 41Gut Health

RCT of 41 patients with mild to moderate ulcerative colitis comparing synbiotic treatment with Bifidobacterium breve strain Yakult and galacto-oligosaccharide to control. The synbiotic group showed significant improvement in clinical status, reduced myeloperoxidase levels, and decreased fecal Bacteroidaceae counts and pH.

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2009·Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer·Mariko Wada, Satoru Nagata, Masahiro Saito, et al

Effects of the enteral administration of Bifidobacterium breve on patients undergoing chemotherapy for pediatric malignancies.

RCTn = 42Immunity Gut Health

A placebo-controlled trial at Juntendo University Hospital evaluated the effects of enteral administration of Bifidobacterium breve strain Yakult on infection prevention and intestinal environments in 42 pediatric cancer patients undergoing chemotherapy. The probiotic group showed lower frequency of fever, reduced use of intravenous antibiotics, and better maintenance of intestinal microbiota and organic acid levels compared to the placebo group.

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2006·Journal of pediatric gastroenterology and nutrition·Tohru Fujii, Yoshikazu Ohtsuka, Tsubasa Lee, et al

Bifidobacterium breve enhances transforming growth factor beta1 signaling by regulating Smad7 expression in preterm infants.

RCTn = 19Immunity Inflammation

RCT examining the effect of Bifidobacterium breve supplementation on TGF-beta signaling in 19 preterm infants. B. breve group showed elevated serum TGF-beta1 levels and altered Smad expression, suggesting potential benefits in reducing inflammatory and allergic reactions.

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1997·Archives of disease in childhood. Fetal and neonatal edition·H Kitajima, Y Sumida, R Tanaka, et al

Early administration of Bifidobacterium breve to preterm infants: randomised controlled trial.

RCTn = 91Gut Health Nutrition

RCT investigating the colonisation of Bifidobacterium breve in very low birthweight infants. The study found that early administration of B breve significantly decreased aspirated air volume from the stomach and improved weight gain, suggesting effective colonisation and positive effects on gut health and nutrition.

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2021·Oncoimmunology·Qingxiang Li, Yuke Li, Yifei Wang, et al

Oral administration of Bifidobacterium breve promotes antitumor efficacy via dendritic cells-derived interleukin 12

Animal studyImmunity

The study investigates the antitumor efficacy of oral administration of Bifidobacterium breve in an animal model. It found that B. breve significantly inhibited tumor growth and up-regulated tumor cell apoptosis through the recruitment of tumor-infiltrating lymphocytes and dendritic cells, enhancing interleukin 12 secretion.

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1999·Kansenshogaku zasshi. The Journal of the Japanese Association for Infectious Diseases·K Araki, T Shinozaki, Y Irie, et al

[Trial of oral administration of Bifidobacterium breve for the prevention of rotavirus infections].

RCTn = 19Immunity

RCT evaluating the effect of Bifidobacterium breve YIT4064 on preventing rotavirus infection in infants. The B. breve group showed significantly lower rotavirus shedding and increased anti-IgA in stool samples compared to the control group.

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2008·Digestive diseases and sciences·Kentaro Shimizu, Hiroshi Ogura, Miki Goto, et al

Synbiotics decrease the incidence of septic complications in patients with severe SIRS: a preliminary report.

Observationaln = 29Gut Health Immunity

Observational study of 29 SIRS patients receiving synbiotics compared to 26 patients without. Synbiotics improved gut flora and reduced the incidence of infectious complications such as enteritis, pneumonia, and bacteremia.

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