Trial reportNutrition journal2022
Safety and efficacy of a probiotic-containing infant formula supplemented with 2'-fucosyllactose: a double-blind randomized controlled trial.
Trial report in Nutrition journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03090360 (Growth of Infants Fed a New Term Infant Formula With a Prebiotic), which is not on this map. Cited by 36 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.
Growth of Infants Fed a New Term Infant Formula With a Prebiotic
Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The Impact of Cesarean Section Delivery on Intestinal Microbiota: Mechanisms, Consequences, and Perspectives-A Systematic Review.International journal of molecular sciences · 2024Pooled it
- Clinical Studies on the Supplementation of Manufactured Human Milk Oligosaccharides: A Systematic Review.Nutrients · 2023Pooled it
- 2'-Fucosyllactose Effects on Preterm Growth, Tolerance, and Neurobehavior: A Double-Blind, Randomized, Placebo-Controlled Pilot.Nutrients · 2026Trial
- New infant formulas for healthy term infants: A randomized, controlled, double-blind, multicenter, non-inferiority design safety study.PloS one · 2025Trial
- Trial
- Orchestrating life's first community: molecular assembly by human milk oligosaccharides.Gut microbes · 2026Review
- Glycosylation in gut-brain communication: from the intestinal barrier and microbiota to immune and neural signaling.Gut microbes · 2026Review
- A Comprehensive Review of Fucosylated Human Milk Oligosaccharides: Biological Functions, Production Technologies, and Safety Regulation With Commercial Translation in Infant Nutrition.Comprehensive reviews in food science and food safety · 2026Review
- Human Milk as a Model for Next-Generation Infant Formula: Opportunities and Challenges.Advances in nutrition (Bethesda, Md.) · 2026Review
- Ratio-Dependent Regulation of Butyrate Production by 2'-Fucosyllactose and Fructooligosaccharides in aMicroorganisms · 2026Article
- Synergistic regulation of gut microbiota and metabolites by breast milk and probiotics in the prevention of neonatal necrotizing enterocolitis: mechanisms and prospects.Translational pediatrics · 2026Review
- A Scoping Review of Instruments Used to Measure Weight and Body Composition in Infants Under 1 Year.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2026Article
- Limited Evidence of Benefits from Clinical Trials of Human-Identical Milk Oligosaccharides for Infants.Advances in nutrition (Bethesda, Md.) · 2026Review
- Early life gut microbiome and its impact on childhood health and chronic conditions.Gut microbes · 2025Review
- Microbiome in heritage: how maternal microbiome transmission impacts next generation health.Microbiome · 2025Review
- Consequences of host-microbiome interactions in preterm infants.Infection and immunity · 2025Review
- Individual and Combined Effects of 2'-Fucosyllactose and Bifidobacterium longum subsp. infantis on the Gut Microbiota Composition of Piglets.The Journal of nutrition · 2025Article
- Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides,Frontiers in nutrition · 2025Article
- Exploring human milk oligosaccharides: mechanisms linking gut function to cognitive development in human and pig physiology.Frontiers in nutrition · 2025Review
- Clinical evidence and mechanistic pathways of human milk oligosaccharide supplementation for health benefits: an updated review.Frontiers in nutrition · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHuman milk oligosaccharides (HMOs) have important and diverse biological functions in early life. This study tested the safety and efficacy of a starter infant formula containing Limosilactobacillus (L.) reuteri DSM 17938 and supplemented with 2'-fucosyllactose (2'FL).
methodsHealthy infants < 14 days old (n = 289) were randomly assigned to a bovine milk-based formula containing L. reuteri DSM 17938 at 1 × 10
resultsWeight gain in EG was non-inferior to CG as shown by a mean difference [95% CI] of 0.26 [-1.26, 1.79] g/day with the lower bound of the 95% CI above the non-inferiority margin (-3 g/day). Anthropometric Z-scores, parent-reported stooling characteristics, gastrointestinal symptoms and associated behaviors, and AEs were comparable between formula groups. Redundancy analysis indicated that the microbiota composition in EG was different from CG at age 2 (p = 0.050) and 3 months (p = 0.052), approaching BF. Similarly, between sample phylogenetic distance (weighted UniFrac) for BF vs EG was smaller than for BF vs CG at 3-month age (p = 0.045). At age 1 month, Clostridioides difficile counts were significantly lower in EG than CG. Bifidobacterium relative abundance in EG tracked towards that in BF. Fecal biomarkers and metabolic profile were comparable between CG and EG.
conclusionL. reuteri-containing infant formula with 2'FL supports age-appropriate growth, is well-tolerated and may play a role in shifting the gut microbial pattern towards that of breastfed infants.
trial registrationThe trial was registered on ClinicalTrials.gov ( NCT03090360 ) on 24/03/2017.
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.