Trial reportBMC pediatrics2017
Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial.
Trial report in BMC pediatrics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 40 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.
Infant Supplementation With Probiotic Bifidobacterium Longum Subsp. Infantis Study
Pilot of a Prebiotic and Probiotic Trial in Young Infants With Severe Acute Malnutrition
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
Who cites it
40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 67 citations in OpenAlex.
- Probiotics in Term Infants: Clinical Impact of Infant-Type Bifidobacteria: A Systematic Review and Meta-analyses.The Journal of nutrition · 2025Pooled it
- Probiotic Supplementation for Promotion of Growth in Children: A Systematic Review and Meta-Analysis.Nutrients · 2021Pooled it
- Probiotic Supplementation During the Perinatal and Infant Period: Effects on Gut Dysbiosis and Disease.Nutrients · 2020Pooled it
- Trial
- Safety and Tolerance ofNutrients · 2025Trial
- Early probiotic supplementation with B. infantis in breastfed infants leads to persistent colonization at 1 year.Pediatric research · 2022Trial
- Pilot study of probiotic/colostrum supplementation on gut function in children with autism and gastrointestinal symptoms.PloS one · 2019Trial
- CAMEO: a CAZyme mapping engine optimized for HUMAnN.Microbiology resource announcements · 2026Article
- Safety, tolerability, and gastrointestinal effect of a Bifidobacterium-based synergistic synbiotic in infants and toddlers.Pediatric research · 2026Article
- Immune development in early life.Nature immunology · 2026Review
- Breastfeeding may lessen socioeconomic disparities in child health through differences in the infant gut microbiome.Cell reports. Medicine · 2026Article
- Neonatal faecal abundance ofGut microbiome (Cambridge, England) · 2026Article
- Bifidobacterium longum subsp infantis (EVC001) is associated with reduced incidence of necrotizing enterocolitis stage ≥2 and bloody stools in premature babies.Journal of perinatology : official journal of the California Perinatal Association · 2025Article
- Individual and Combined Effects of 2'-Fucosyllactose and Bifidobacterium longum subsp. infantis on the Gut Microbiota Composition of Piglets.The Journal of nutrition · 2025Article
- Clinical effects ofFrontiers in nutrition · 2025Article
- Impact ofNutrients · 2024Review
- Contemporary use of prophylactic probiotics in NICUs in the United States: a survey update.Journal of perinatology : official journal of the California Perinatal Association · 2024Article
- Interactions between the human milk oligosaccharide 2'-fucosyllactose andFrontiers in nutrition · 2024Article
- Safety, efficacy, and impact on gut microbial ecology of aFrontiers in nutrition · 2023Article
- Factors influencing development of the infant microbiota: from prenatal period to early infancy.Clinical and experimental pediatrics · 2022Article
Corrections and comments
- Erratum issued
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHistorically, bifidobacteria were the dominant intestinal bacteria in breastfed infants. Still abundant in infants in developing nations, levels of intestinal bifidobacteria are low among infants in developed nations. Recent studies have described an intimate relationship between human milk and a specific subspecies of Bifidobacterium, B. longum subsp. infantis (B. infantis), yet supplementation of breastfed, healthy, term infants with this organism, has not been reported. The IMPRINT Study, a Phase I clinical trial, was initiated to determine the safety and tolerability of supplementing breastfed infants with B. infantis (EVC001).
methodsEighty mother-infant dyads were enrolled in either lactation support plus B. infantis supplementation (BiLS) or lactation support alone (LS). Starting with Day 7 postnatal, BiLS infants were fed 1.8-2.8 × 10
resultsThere were no differences in the mean gestational age at birth, weight 1 and 2 months postnatal, and breast milk intake between groups. The mean Log
conclusionsThe B. infantis EVC001 supplement was safely consumed and well-tolerated. Stools were fewer and better formed in infants in the BiLS group compared with LS group. Adverse events were those expected in healthy infants and not different between groups.
trial registrationClinicalTrials.gov NCT02457338 . Registered May 27, 2015.
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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.