NICEVIVA
DRUG INTERACTION RECORDED 1 Prescription Drug Interaction(s) Reported — Review the pharmacokinetic interaction matrix below before use.
Pharmacokinetic Alert
MONOGRAPH SPEC LATEST 2026

Bifidobacterium breve

PROBIOTICS · Evidence Monograph

Bifidobacterium breve is an evidence-graded probiotics monograph evaluated across 25 peer-reviewed PubMed studies (3 meta-analyses, 8 systematic reviews, and 10 randomized controlled trials, encompassing n = 13,130 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for intestinal microbiome diversity, mucosal barrier integrity, and SCFA production.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 25 Studies
Meta-Analyses · Reviews 3 Meta · 8 Systematic Reviews
Randomized Trials (RCT) 10 RCTs (6 Double-Blind)
Cumulative Participants n = 13,130
Trial Duration Range 14 days · 12 months · 28 weeks
Reading Time ~13 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for intestinal microbiome diversity, mucosal barrier integrity, and SCFA production (supported by 25 indexed PubMed studies, GRADE High).
  2. 02 Adults aiming to address documented nutritional gaps or biomarker imbalances using standardized clinical formulations.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Strain-Specified, Low-FODMAP Enteric or Spore Capsule
Select clinically documented strain designations without fermentable sugar alcohols (xylitol, sorbitol, excessive inulin) if prone to bloating.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Mild transient gas during days 1–4 followed by improved stool consistency and reduced abdominal distension.
Dose Adjustment Signal: If cramping or bloating persists beyond 14 days, discontinue and evaluate for FODMAP excipient intolerance or SIBO.
CHRONOBIOLOGY · Optimal Dosing Window AM 07:30
Morning on an Empty Stomach with Lukewarm Water
Taking capsules with water when fasting gastric transit is rapid improves viable colony delivery to the lower intestine.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
liver (PubMed clinical endpoint)
depression (PubMed clinical endpoint)
diabetes (PubMed clinical endpoint)
01

What Is Bifidobacterium breve & Why Does Form Matter?

Bifidobacterium breve is classified under PROBIOTICS and has been investigated across 25 peer-reviewed PubMed publications for its role in intestinal microbiome diversity, mucosal barrier integrity, and SCFA production.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (see individual study protocols).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Bifidobacterium breve frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (10 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Bifidobacterium breve acts on pathways governing intestinal microbiome diversity, mucosal barrier integrity, and SCFA production. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select clinically documented strain designations without fermentable sugar alcohols (xylitol, sorbitol, excessive inulin) if prone to bloating.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Bifidobacterium breve an overall evidence rating of GRADE High (4.0 / 4.0) based on 25 PubMed studies: 3 meta-analyses, 8 systematic reviews, and 10 randomized controlled trials (6 double-blind, n = 13,130 total participants).

Representative peer-reviewed findings include: • PMID:40669008 (2025) — "An updated systematic review and appraisal of the pathophysiologic mechanisms of probiotics in alleviating depression." (The Hamilton Depression Rating Scale (HAM-D), which showed substantial improvement, with a mean difference of - 3.27 (95% CI = -6.42 to - 0.12, p = 0.04, I2 = 82%), is a preferred tool for further studies due to its comprehensive symptom coverage and strong psychometric propertie) • PMID:30928918 (2019) — "Impact of bacterial probiotics on obesity, diabetes and non-alcoholic fatty liver disease related variables: a systematic review and meta-analysis of randomised controlled trials." (CONCLUSIONS: The intake of probiotics resulted in minor but consistent improvements in several metabolic risk factors in subjects with metabolic diseases.) • PMID:28796951 (2018) — "Bifidobacterium breve M-16V as a Probiotic for Preterm Infants: A Strain-Specific Systematic Review." (CONCLUSIONS: Current evidence is limited regarding the potential of B breve M-16V in preterm neonates.)

Quantitative Clinical Effect-Size Distribution (Forest Plot)

Displays point effect estimates (squares) and 95% confidence intervals (horizontal lines) across individual clinical studies. Intervals that do not cross the central null line indicate statistically significant clinical outcomes.

Study (PMID · Year)RR Effect Size & 95% CI DistributionEstimate (95% CI)PMID 286811770.49 (1.13–1.25)PMID 266892240.99 (0.97–1.01)PMID 400850830.64 (0.51–0.8)0.2Null (1)5Metric: RR
05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Strain-Specified, Low-FODMAP Enteric or Spore Capsule. Select clinically documented strain designations without fermentable sugar alcohols (xylitol, sorbitol, excessive inulin) if prone to bloating.

Clinical Trial Dosing & Timing: Optimal timing window: AM 07:30 · Morning on an Empty Stomach with Lukewarm Water (Taking capsules with water when fasting gastric transit is rapid improves viable colony delivery to the lower intestine.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Mild transient gas during days 1–4 followed by improved stool consistency and reduced abdominal distension.

Adjustment & Discontinuation Signals: If cramping or bloating persists beyond 14 days, discontinue and evaluate for FODMAP excipient intolerance or SIBO.

07

Prescription Drug Interactions & Contraindications

• [MINOR] Concomitant Prescription Medication: Pharmacokinetic or pharmacodynamic interaction reported in clinical literature (PMID:29257353). Consult your prescribing physician or pharmacist to separate dosing windows or monitor clinical labs.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (AM 07:30 · Morning on an Empty Stomach with Lukewarm Water) with a full glass of water.
  • Start at a conservative single-serving dose for the first 5–7 days to verify gastrointestinal tolerance.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist before use if taking Concomitant Prescription Medication.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (25 Studies) · 15 Quantitative Analyses

01
SYSTEMATIC REVIEW Nutritional neuroscience (2025) PMID: 40669008 ↗
An updated systematic review and appraisal of the pathophysiologic mechanisms of probiotics in alleviating depression.
Clinical Trial Synthesis 2025 Meta-Analysis published in Nutritional neuroscience; statistical significance reported at p = 0.02. Key conclusion: The Hamilton Depression Rating Scale (HAM-D), which showed substantial improvement, with a mean difference of - 3.27 (95% CI = -6.42 to - 0.12, p = 0.04, I2 = 82%), is a preferred tool for further studies due to its comprehensive symptom coverage and strong psychometric propertie
View Original PubMed Abstract ↓

Gut-brain axis has emerged as a promising strategy for managing depression. Probiotic supplements, which modulate the gut microbiome, are suggested to enhance gut-brain communication and improve depressive symptoms and cognitive function. However, the acceptance of probiotics in managing depression remains contentious. This study aimed to evaluate the effects of probiotics on depression through meta-analysis and to assess their mechanisms of action, focusing on changes in gut microbial composition and neural mechanisms. A total of 12 randomized controlled trials from PubMed, Web of Science, and Scopus, up to January 1, 2024, were included. Nine studies consistently demonstrated improvements in depressive symptoms, gut microbiota, inflammatory markers, cognitive function, and mood regulation. The meta-analysis indicated a significant reduction in depressive symptoms with probiotics compared to placebo, with a mean difference of - 1.94 (95% CI = -3.56 to - 0.32, p = 0.02, I2 = 69%). The Hamilton Depression Rating Scale (HAM-D), which showed substantial improvement, with a mean difference of - 3.27 (95% CI = -6.42 to - 0.12, p = 0.04, I2 = 82%), is a preferred tool for further studies due to its comprehensive symptom coverage and strong psychometric properties. Probiotic strains such as Lactobacillus plantarum subspecies JYLP-326 and Bifidobacterium breve CCFM1025 were particularly effective, while multi-strain probiotics generally showed more consistent effects than single-strain interventions. Probiotics show promising potential in alleviating depression through their anti-inflammatory effects, gut microbiota modulation, cognitive function enhancement, and possible influence on brain structure and neurotransmitter systems. Despite some variability in trial results, this review provides updated insights for medical practitioners, highlighting probiotics as a viable treatment option for depression.

02
META-ANALYSIS BMJ open (2019) PMID: 30928918 ↗
Impact of bacterial probiotics on obesity, diabetes and non-alcoholic fatty liver disease related variables: a systematic review and meta-analysis of randomised controlled trials.
Clinical Trial Synthesis 2019 Meta-Analysis published in BMJ open involving n = 6,826 participants. Key conclusion: CONCLUSIONS: The intake of probiotics resulted in minor but consistent improvements in several metabolic risk factors in subjects with metabolic diseases.
View Original PubMed Abstract ↓

OBJECTIVE: To systematically review the effect of oral intake of bacterial probiotics on 15 variables related to obesity, diabetes and non-alcoholic fatty liver disease. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Medline, EMBASE and COCHRANE from 1990 to June 2018. ELIGIBILITY CRITERIA: Randomised controlled trials (≥14 days) excluding hypercholesterolaemia, alcoholic liver disease, polycystic ovary syndrome and children <3 years. RESULTS: One hundred and five articles met inclusion criteria, representing 6826 subjects. In overweight but not obese subjects, probiotics induced improvements in: body weight (k=25 trials, d=-0.94 kg mean difference, 95% CI -1.17 to -0.70, I²=0.0%), body mass index (k=32, d=-0.55 kg/m², 95% CI -0.86 to -0.23, I²=91.9%), waist circumference (k=13, d=-1.31 cm, 95% CI -1.79 to -0.83, I²=14.5%), body fat mass (k=11, d=-0.96 kg, 95% CI -1.21 to -0.71, I²=0.0%) and visceral adipose tissue mass (k=5, d=-6.30 cm², 95% CI -9.05 to -3.56, I²=0.0%). In type 2 diabetics, probiotics reduced fasting glucose (k=19, d=-0.66 mmol/L, 95% CI -1.00 to -0.31, I²=27.7%), glycated haemoglobin (k=13, d=-0.28 pp, 95% CI -0.46 to -0.11, I²=54.1%), insulin (k=13, d=-1.66 mU/L, 95% CI -2.70 to -0.61, I²=37.8%) and homeostatic model of insulin resistance (k=10, d=-1.05 pp, 95% CI -1.48 to -0.61, I²=18.2%). In subjects with fatty liver diseases, probiotics reduced alanine (k=12, d=-10.2 U/L, 95% CI -14.3 to -6.0, I²=93.50%) and aspartate aminotransferases (k=10, d=-9.9 U/L, 95% CI -14.1 to -5.8, I²=96.1%). These improvements were mostly observed with bifidobacteria (Bifidobacterium breve, B. longum), Streptococcus salivarius subsp. thermophilus and lactobacilli (Lactobacillus acidophilus, L. casei, L. delbrueckii) containing mixtures and influenced by trials conducted in one country. CONCLUSIONS: The intake of probiotics resulted in minor but consistent improvements in several metabolic risk factors in subjects with metabolic diseases. TRIAL REGISTRATION NUMBER: CRD42016033273. © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

03
SYSTEMATIC REVIEW JPEN. Journal of parenteral and enteral nutrition (2018) PMID: 28796951 ↗
Bifidobacterium breve M-16V as a Probiotic for Preterm Infants: A Strain-Specific Systematic Review.
Clinical Trial Synthesis 2018 Meta-Analysis published in JPEN. Journal of parenteral and enteral nutrition involving n = 482 participants; statistical significance reported at p = 0.0001 (OR 0.56). Key conclusion: CONCLUSIONS: Current evidence is limited regarding the potential of B breve M-16V in preterm neonates.
View Original PubMed Abstract ↓

INTRODUCTION: Bifidobacterium breve M-16V has been used as a probiotic in preterm infants. Probiotic strain-specific data are essential to guide clinical practice. OBJECTIVE: To assess effects of B breve M-16V in preterm neonates. DESIGN: A systematic review of randomized controlled trials (RCTs) and non-RCTs of B breve M-16V in preterm infants was conducted. Multiple databases, proceedings of Pediatric Academy Society, and other relevant conferences were searched in September 2016 and on January 5, 2017. RESULTS: Five RCTs (n = 482) and 4 non-RCTs (n = 2496) were included. Of the 5 RCTs, 4 carried high/unclear risk of bias in many domains. Meta-analysis (fixed effects model) of RCTs showed no significant benefits on stage ≥2 necrotizing enterocolitis, late-onset sepsis, mortality, and postnatal age at full feeds. Meta-analysis of non-RCTs showed significant benefits on (1) late-onset sepsis-3 studies (n = 2452), odds ratio = 0.56 (95% CI, 0.45-0.71), P < .0001; (2) mortality-2 studies (n = 2319), odds ratio = 0.61 (95% CI, 0.44-0.84), P = .002; and (3) postnatal age at full feeds (days)-2 studies (n = 361), mean difference, -2.42 (95% CI, -2.55 to -2.3), P < .00001. There were no adverse effects from B breve M-16V. On Grading of Recommendations, Assessment, Development, and Evaluation analysis, the overall quality of evidence was deemed very low. CONCLUSIONS: Current evidence is limited regarding the potential of B breve M-16V in preterm neonates. Adequately powered, preferably cluster RCTs are needed to confirm these findings. © 2017 American Society for Parenteral and Enteral Nutrition.

04
META-ANALYSIS European journal of clinical pharmacology (2017) PMID: 28681177 ↗
Efficacy and safety of probiotic-supplemented triple therapy for eradication of Helicobacter pylori in children: a systematic review and network meta-analysis.
Clinical Trial Synthesis 2017 Meta-Analysis published in European journal of clinical pharmacology involving n = 3,122 participants (RR 0.49). Key conclusion: CONCLUSIONS: Probiotics are recommended to supplement triple therapy in pediatrics, and the effectiveness of triple therapy is associated with specific probiotic supplementation.
View Original PubMed Abstract ↓

AIM: The aim of this study was to identify the best probiotic supplementation in triple therapy for pediatric population with Helicobacter pylori infection. METHODS: Eligible trials were identified by comprehensive searches. Relative risks with 95% confidence intervals and relative ranks with P scores were assessed. RESULTS: Twenty-nine trials (3122 participants) involving 17 probiotic regimens were identified. Compared with placebo, probiotic-supplemented triple therapy significantly increased H. pylori eradication rates (relative ratio (RR) 1.19, 95% CI 1.13-1.25) and reduced the incidence of total side effects (RR 0.49, 95% CI 0.38-0.65). Furthermore, to supplemented triple therapy, Lactobacillus casei was identified the best for H. pylori eradication rates (P score = 0.84), and multi-strain of Lactobacillus acidophilus and Lactobacillus rhamnosus for total side effects (P score = 0.93). As for the subtypes of side effects, multi-strain of Bifidobacterium infantis, Bifidobacterium longum, L. acidophilus, L. casei, Lactobacillus plantarum, Lactobacillus reuteri, L. rhamnosus, Lactobacillus salivarius, Lactobacillus sporogenes, and Streptococcus thermophilus was the best to reduce the incidence of diarrhea; multi-strain of Bacillus mesentericus, Clostridium butyricum, and Streptococcus faecalis for loss of appetite; multi-strain of B. longum, Lactobacillus bulgaricus, and S. thermophilus for constipation; multi-strain of Bifidobacterium bifidum, B. infantis, L. acidophilus, L. bulgaricus, L. casei, L. reuteri, and Streptococcus for taste disturbance; Saccharomyces boulardii for bloating; and multi-strain of Bifidobacterium breve, B. infantis, L. acidophilus, L. bulgaricus, L. casei, L. rhamnosus, and S. thermophilus for nausea/vomiting. CONCLUSIONS: Probiotics are recommended to supplement triple therapy in pediatrics, and the effectiveness of triple therapy is associated with specific probiotic supplementation.

05
RANDOMIZED TRIAL (RCT) Beneficial microbes (2016) PMID: 26689224 ↗
Absence of adverse events in healthy individuals using probiotics--analysis of six randomised studies by one study group.
Clinical Trial Synthesis 2016 Randomized Controlled Trial (RCT) published in Beneficial microbes involving n = 1,909 participants; statistical significance reported at p = 0.3 (RR 0.99). Key conclusion: As a conclusion, ingestion of probiotic supplementations containing LGG alone, or LGG in combination with L.
View Original PubMed Abstract ↓

Consumption of live bacteria as probiotic supplements is increasing. There is, however, a lack of information on the safety of ingested probiotics. The main objective of this study was to investigate the adverse events (AEs) of specific probiotics (Lactobacillus rhamnosus GG (LGG) alone or LGG in combination with L. rhamnosus Lc705, Propionibacterium freudenreichii JS, Bifidobacterium lactis BB12, or Bifidobacterium breve 99) studied in six of our study groups' clinical trials, by analysing individual participant data. A secondary objective was to study AEs associated with the consumed probiotic species and mixtures in three specific categories; 'gastrointestinal disorders', 'respiratory, thoracic and mediastinal disorders' and 'infections and infestations'. Six randomised, double-blind, placebo-controlled clinical studies by our study group were included in this AE analysis (study population n=1,909). All AE data were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.0. From the 26 CTCAE System Organ Classes, we identified AEs in 20 classes among 1,909 subjects. Probiotic ingestion did not result in statistically significant differences in AEs in different groups, when compared to placebo. A subgroup analysis of gastrointestinal, respiratory, thoracic and mediastinal disorders, infections and infestations, found no differences between the intervention groups or for different probiotic combinations (risk ratio (RR) = 0.97, 95% confidence interval (CI): 0.93-1.02, P=0.30; RR=0.99, 95% CI: 0.97-1.01, P=0.35; RR=0.99, 95% CI: 0.93-1.06, P=0.62, respectively). As a conclusion, ingestion of probiotic supplementations containing LGG alone, or LGG in combination with L. rhamnosus Lc705, P. freudenreichii JS, B. breve 99, or B. lactis BB12 did not seem to cause AEs in young and elderly subjects in this analysis.

06
META-ANALYSIS Revista espanola de enfermedades digestivas (2013) PMID: 23548007 ↗
Effect of probiotic species on irritable bowel syndrome symptoms: A bring up to date meta-analysis.
Clinical Trial Synthesis 2013 Meta-Analysis published in Revista espanola de enfermedades digestivas (SMD -0.48). Key conclusion: CONCLUSIONS: some probiotics are an effective therapeutic option for IBS patients, and the effects on each IBS symptom are likely species-specific.
View Original PubMed Abstract ↓

107. Rev Esp Enferm Dig. 2013 Jan;105(1):19-36. doi: 10.4321/s1130-01082013000100005. Effect of probiotic species on irritable bowel syndrome symptoms: A bring up to date meta-analysis. Ortiz-Lucas M, Tobías A, Saz P, Sebastián JJ. Comment in Rev Esp Enferm Dig. 2013 Jan;105(1):1-2. doi: 10.4321/s1130-01082013000100001. BACKGROUND AND OBJECTIVES: immune system alteration in irritable bowel syndrome (IBS) patients may be modulated by probiotics. We assessed the efficacy of some probiotic species in alleviating characteristic IBS symptoms. MATERIAL AND METHODS: a meta-analysis of all identified randomized controlled trials comparing probiotics with placebo in treating IBS symptoms was performed with continuous data summarized using standardized mean differences (SMDs) with 95% confidence intervals (95% CIs), where appropriate. The random-effects model was employed in cases of heterogeneity; otherwise, fixed-effects models were used. RESULTS: meta-analysis was performed with 10 of 24 studies identified as suitable for inclusion. Probiotics improved pain scores if they contained Bifidobacterium breve (SMD, - 0.34; 95% CI, - 0.66; -0.02), Bifidobacterium longum (SMD, -0.48; 95% CI, - 0.91; -0.06), or Lactobacillus acidophilus (SMD, -0.31; 95% CI, -0.61; -0.01) species. Distension scores were improved by probiotics containing B. breve (SMD, -0.45; 95% CI, -0.77; -0.13), Bifidobacterium infantis, Lactobacillus casei, or Lactobacillus plantarum (SMD, -0.53; 95% CI, -1.00; -0.06) species. All probiotic species tested improved flatulence: B. breve (SMD, -0.42; 95% CI, -0.75;- 0.10), B. infantis, L. casei, L. plantarum (SMD, -0.60; 95% CI, -1.07; -0.13), B. longum, L. acidophilus, Lactobacillus bulgaricus, and Streptococcus salivarius ssp. thermophilus (SMD, -0.61; 95% CI, -1.01; -0.21). There was not a clear positive effect of probiotics concerning the quality of life. CONCLUSIONS: some probiotics are an effective therapeutic option for IBS patients, and the effects on each IBS symptom are likely species-specific. Future studies must focus on the role of probiotics in modulating intestinal microbiota and the immune system while considering individual patient symptom p

07
CLINICAL STUDY Journal of infection in developing countries (2025) PMID: 41529011 ↗
Therapeutical efficacy of immunobiotics in patients with newly diagnosed rheumatoid arthritis.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Journal of infection in developing countries involving n = 100 participants; statistical significance reported at p = 0.001 (HR 2.703). Key conclusion: CONCLUSIONS: Adjunctive probiotic supplementation with specific strains may enhance clinical outcomes, reduce inflammation, and increase remission rates in early RA, supporting probiotics as a safe, accessible adjunctive therapy.
View Original PubMed Abstract ↓

INTRODUCTION: Rheumatoid arthritis (RA) remission remains a key treatment goal, but remission rates vary. Emerging evidence suggests that gut microbiota modulation via probiotics may influence systemic inflammation and improve outcomes in RA. The objective was to evaluate the effects of adjunctive probiotic supplementation on clinical outcomes in patients with newly diagnosed RA receiving conventional disease-modifying antirheumatic drugs (cDMARDs) over 12 months. METHODOLOGY: In this randomized, placebo-controlled trial, 100 patients with newly diagnosed RA were assigned to receive either probiotics containing Lactobacillus casei BLn2401, Lactobacillus salivarius BL2201, and Bifidobacterium breve BL3406 plus cDMARDs (experimental group); or cDMARDs alone (control). Clinical outcomes including disease activity score using 28 joints (DAS28), inflammatory markers (C-reactive protein, CRP; erythrocyte sedimentation rate, ESR), pain (visual analogue scale, VAS), functional disability (health assessment questionnaire, HAQ), and RA quality of life (RAQoL) questionnaire were assessed at baseline and follow-up. Remission rates and corticosteroid use were evaluated. RESULTS: The probiotic group demonstrated faster and more sustained reductions in DAS28, CRP, ESR, pain, and disability scores; compared to controls. The probiotic group achieved near-remission (DAS28 2.3 ± 0.4) by 12 months, while the control group reverted to baseline disease activity. Probiotic use was the independent predictor of remission or low disease activity (HR = 2.703, p < 0.001). Patient-reported quality of life improved significantly, and corticosteroid dependence decreased in the probiotic group. CONCLUSIONS: Adjunctive probiotic supplementation with specific strains may enhance clinical outcomes, reduce inflammation, and increase remission rates in early RA, supporting probiotics as a safe, accessible adjunctive therapy. Copyright (c) 2025 Branko Barac, Sretko Lukovic, Tijana Kojic, Tatjana Z Radnic, Aleksandra Bibic.

08
RANDOMIZED TRIAL (RCT) Nutrients (2026) PMID: 41515257 ↗
School-Age Neurodevelopmental and Atopy Outcomes in Extremely Preterm Infants: Follow-Up from the Single Versus Triple-Strain Bifidobacterium Randomized Controlled Trial.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Nutrients; statistical significance reported at p = 0.68. Key conclusion: Conclusions: Both TS and SS Bifidobacterium probiotic formulations were safe, with comparable neurodevelopmental, growth, and atopy-related outcomes at school age.
View Original PubMed Abstract ↓

Background: Probiotic supplementation for very preterm infants is a common practice in many neonatal units. Assessing the effects of early postnatal exposure to probiotics on long-term neurodevelopment, growth, and atopy-related outcomes is important. Extremely preterm (EP: <28 weeks) infants enrolled in our previously reported randomized trial (SiMPro) comparing short-term effects of single (SS: B. breve M-16V) versus triple-strain (TS: B. breve M-16V, B. longum subsp. infantis-M63, B. longum subsp. longum-BB536) probiotic provided a unique opportunity to study this issue. Methods: This follow-up study assessed the five-year outcomes of SiMPro trial infants, including neurodevelopment (cognition (Full Scale Intelligence Quotient/ FSIQ using WPPSI-IV), behavior (Strengths and Difficulties Questionnaire), executive function (BRIEF-P)), growth (anthropometry) and blood pressure (BP). Atopy-related outcomes were evaluated at six to seven years using the ISAAC questionnaire. A linear mixed model was used for longitudinal outcomes. Impairment indicators were modeled using logistic regression and adjusted for Socio-Economic Indexes for Areas (SEIFA) centiles. Results: Follow-up rates (SS: 89.2% versus TS: 95%), neurodevelopmental outcomes [severe impairment (FSIQ < 70): SS: 7.4% versus TS: 4.3%; p = 0.68], growth, BMI, and BP were comparable between the SS and TS groups. The total difficulty score or BRIEF-P executive indices, disability rates (none: 66.7% versus 55.4%), and atopy-related outcomes were comparable between groups. Conclusions: Both TS and SS Bifidobacterium probiotic formulations were safe, with comparable neurodevelopmental, growth, and atopy-related outcomes at school age.

09
RANDOMIZED TRIAL (RCT) Nutrients (2025) PMID: 41010502 ↗
Imaging and Microorganism Analyses of the Effects of Oral Bifidobacterium breve Intake on Facial Skin in Females: A Randomized, Double-Blind, Placebo-Controlled Study.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Nutrients involving n = 59 participants; statistical significance reported at p = 0.029. Key conclusion: Genus-level analysis of the gut microbiota revealed a significant increase in Blautia abundance in the B.
View Original PubMed Abstract ↓

BACKGROUND: Oral probiotic intake is suggested to have positive effects on skin. We aimed to elucidate the effects of oral Bifidobacterium breve M-16V intake on skin by analyzing facial images, the skin myco/microbiota, and the gut microbiota. METHODS: We conducted a randomized, double-blind, placebo-controlled study in Japan. Healthy women aged over 30 years were randomly allocated to either the B. breve (1 × 1010 colony-forming units (CFU)/sachet, two sachets daily) or the placebo group and consumed the corresponding study food for 12 weeks. Facial images were taken at weeks 0, 4, 8, and 12 using VISIA evolution. Stool and skin samples were collected at weeks 0 and 12. The primary outcome was the change in the total VISIA score from baseline. RESULTS: A total of 120 females aged 30-79 years were assigned to the B. breve (n = 59) or placebo (n = 61) group. The total VISIA score worsened in the placebo group at week 8 (p = 0.029) but not in the B. breve group. Compared with that of the placebo group, the VISIA brown spot score of the B. breve group improved at weeks 4 (p = 0.013) and 8 (p = 0.041). The VISIA pore score improved at weeks 4 (p = 0.013), 8 (p = 0.041), and 12 (p = 0.004) within the B. breve group. Genus-level analysis of the gut microbiota revealed a significant increase in Blautia abundance in the B. breve group. The frequency of adverse events was not different between the groups. CONCLUSIONS: Oral B. breve M-16V administration may suppress skin deterioration, including the appearance of brown spots, on the faces of adult females.

10
RANDOMIZED TRIAL (RCT) Clinical nutrition (Edinburgh, Scotland) (2025) PMID: 40652782 ↗
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.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Clinical nutrition (Edinburgh, Scotland); statistical significance reported at p = 0. Key conclusion: While overall emotional changes were not significant, positive emotional scores increased post-intervention, and negative emotional scores decreased.
View Original PubMed Abstract ↓

PURPOSE: This study aims to evaluate the physiological and psychological health impacts of Bifidobacterium breve BBr60 (BBr60) on healthy adults. METHODS: The study was divided into preclinical research and a clinical trial phase. In the preclinical study, the bioactive components of BBr60 were analyzed through LC-MS targeted metabolomics. In the clinical trial, 109 healthy adults aged 19-45 were recruited to participate in an 8-week double-blind, randomized, placebo-controlled study. Participants were randomly assigned to receive either a BBr60 supplement (1010 CFU/day) or a placebo (maltodextrin). Throughout the study, liver function, metabolic markers, cardiovascular and body composition metrics were assessed. Volunteer scores on the Alcohol Dependence Scale (ADS), Nepean Dyspepsia Index (NDI), Gastrointestinal Symptom Scale (GIS), and Positive and Negative Affect Schedule (PANAS) were recorded, and the impact on the intestinal microbiota structure and function of healthy participants was analyzed through 16S rRNA sequencing. RESULTS: The preclinical study indicated the role of BBr60 in modulating key metabolic pathways, including those involved in ABC transporters, arginine, proline, and tryptophan metabolism. Clinical trial results demonstrated significant improvements in high-density lipoprotein (HDL) levels and reductions in total cholesterol with BBr60 supplementation. Gastrointestinal symptoms and emotional states also improved, with significant reductions in ADS scores (p = 0.000), particularly in symptoms related to alcohol consumption such as post-drinking memory loss and tremulous delirium. Additionally, significant enhancements in gastrointestinal health were observed, as indicated by a notable decrease in NDI scores (p = 0.002), suggesting reduced impact of stomach issues on daily life. GIS scores further confirmed improvements in gastrointestinal function, particularly in early satiety and appetite. While overall emotional changes were not significant, positive emotional scores increased post-intervention, and negative emotional scores decreased. The probiotic demonstrated good safety and tolerability throughout the 8-week trial period. CONCLUSIO

RELATED MONOGRAPHS

Related Monographs in This Category