Trial reportAlimentary pharmacology & therapeutics2020
The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB-12
Trial report in Alimentary pharmacology & therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 51 papers, 3 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.
A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Nutritional Intervention Study to Examine the Clinical and Immunological Effects of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis
Efficacy of Bifidobacterium Bifidum on Symptoms of Infant Colic and Atopic Dermatitis: a Randomized Controlled Trial.
Who cites it
51 citing papers in PubMed, 3 syntheses or guidelines pooled it, 86 citations in OpenAlex.
- Pooled it
- 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
- Breastfeeding Affects Concentration of Faecal Short Chain Fatty Acids During the First Year of Life: Results of the Systematic Review and Meta-Analysis.Frontiers in nutrition · 2022Pooled it
- Kefir-derived probiotic mixture for children with autism spectrum disorder: a double-blind randomized clinical trial.BMC pediatrics · 2026Trial
- A synbiotic mixture for the management of infantile colic: A randomized trial.European journal of pediatrics · 2024Trial
- Adjudicative efficacy of Bifidobacterium animalis subsp. lactis BLa80 in treating acute diarrhea in children: a randomized, double-blinded, placebo-controlled study.European journal of clinical nutrition · 2024Trial
- Adjunctive efficacy of Bifidobacterium animalis subsp. lactis XLTG11 for functional constipation in children.Brazilian journal of microbiology : [publication of the Brazilian Society for Microbiology] · 2024Trial
- Probiotic stool secretory immunoglobulin A modulation in children with gastroenteritis: a randomized clinical trial.The American journal of clinical nutrition · 2021Trial
- The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB-12Alimentary pharmacology & therapeutics · 2020Trial
- Development of national consensus-based recommendations for history taking, examination and clinical management of infants in chiropractic practice.Chiropractic & manual therapies · 2026Article
- Current Understanding of Probiotic Strains and Immune Function: From Gut Microbiota to Systemic Immunity.International journal of molecular sciences · 2026Review
- Article
- Insomnia: the gut microbiome connection, prospects for probiotic and postbiotic therapies, and future directions.Journal of advanced research · 2026Review
- Comparative Immunomodulatory Profiles ofJournal of microbiology and biotechnology · 2026Article
- Bifidobacterium animalis subsp. lactis BLa80 for preventing allergic, respiratory, and gastrointestinal diseases in young children in China: a randomized double-blind placebo-controlled trial.Clinical and experimental pediatrics · 2026Article
- Interconnected Developmental Trajectories of the Brain, Gut, and Sleep in Early Life: The First 1000 Days of Nutritional Opportunity.Nutrients · 2026Review
- Health benefits ofFrontiers in microbiology · 2026Review
- The Efficacy of the Administration ofAdvanced biomedical research · 2026Article
- The gut microbiota and sleep in infants: a focus on diurnal rhythmicity patterns.Gut microbes reports · 2026Article
- Why do babies cry? Exploring the role of the gut microbiota in infantile colic, constipation, and cramps in the KOALA birth cohort study.Gut microbes · 2025Article
Corrections and comments
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Authors and funding
18 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundThe pathogenesis of infant colic is poorly defined. Gut microbiota seems to be involved, supporting the potential therapeutic role of probiotics.
aimsTo assess the rate of infants with a reduction of ≥50% of mean daily crying duration after 28 days of intervention with the probiotic Bifidobacterium animalis subsp. lactis BB-12
methodsRandomized controlled trial (RCT) on otherwise healthy exclusively breastfed infants with infant colic randomly allocated to receive BB-12 (1 × 10
resultsEighty infants were randomised, 40/group. The rate of infants with reduction of ≥50% of mean daily crying duration was higher in infants treated with BB-12, starting from the end of 2nd week. No infant relapsed when treatment was stopped. The mean number of crying episodes decreased in both groups, but with a higher effect in BB-12 group (-4.7 ± 3.4 vs -2.3 ± 2.2, P < 0.05). Mean daily stool frequency decreased in both groups but the effect was significantly higher in the BB-12 group; stool consistency was similar between the two groups. An increase in Bifidobacterium abundance (with significant correlation with crying time reduction), butyrate and HBD-2, LL-37, sIgA levels associated with a decrease in faecal calprotectin level were observed in the BB-12 group.
conclusionsSupplementation with BB-12 is effective in managing infant colic. The effect could derive from immune and non-immune mechanisms associated with a modulation of gut microbiota structure and function.
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.