Trial reportGut microbes2015
Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study.
Trial report in Gut microbes, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Safety of One of the Most Commonly Used Probiotic Strains: Systematic Review and Meta-analysis of Reported Adverse Events.Probiotics and antimicrobial proteins · 2026Pooled it
- The effect of bovine dairy products and their components on the incidence and natural history of infection: a systematic literature review.Nutrition journal · 2024Pooled it
- Trial
- Safety and functional enrichment of gut microbiome in healthy subjects consuming a multi-strain fermented milk product: a randomised controlled trial.Scientific reports · 2020Trial
- Safety of Bifidobacterium animalis Subsp. Lactis (B. lactis) Strain BB-12-Supplemented Yogurt in Healthy Children.Journal of pediatric gastroenterology and nutrition · 2017Trial
- Article
- Comparison of Physicochemical, Microbiological, and Sensory Properties of Yogurt Made From Cow, Goat, Sheep, and Buffalo Milk with and Without Probiotic Cultures.Food science & nutrition · 2026Article
- Unlocking the health potential of fermented foods: insights from traditional Indian diets.Frontiers in microbiology · 2026Review
- Key Technologies of Synthetic Biology in Industrial Microbiology.Microorganisms · 2025Review
- Unveiling the Important Role of Gut Microbiota and Diet in Multiple Sclerosis.Brain sciences · 2025Review
- Understanding the probiotic health benefits ofFrontiers in microbiology · 2025Review
- Bifidobacterium animalis subsp. lactis BB-12 attenuates diabetic retinopathy through gut microbiota modulation: evidence for the gut-retinal axis.Frontiers in cellular and infection microbiology · 2025Article
- Heat-KilledNutrients · 2023Article
- Leaky Gut and the Ingredients That Help Treat It: A Review.Molecules (Basel, Switzerland) · 2023Review
- Reduction in the Choking Phenomenon in Elite Diving Athletes Through Changes in Gut Microbiota Induced by Yogurt ContainingMicroorganisms · 2020Article
- Recent Advancements in the Development of Modern Probiotics for Restoring Human Gut Microbiome Dysbiosis.Indian journal of microbiology · 2020Review
- Gut Microbiota Dysbiosis Associated With Altered Production of Short Chain Fatty Acids in Children With Neurodevelopmental Disorders.Frontiers in cellular and infection microbiology · 2020Article
- Article
- Factors Influencing the Gut Microbiota, Inflammation, and Type 2 Diabetes.The Journal of nutrition · 2017Review
- Prevalence of Antibiotic Resistance Genes among Human Gut-Derived Bifidobacteria.Applied and environmental microbiology · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 8 institutions in 4 countries.
Funding
Abstract
Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.