Trial reportBMC microbiology2020
Stool microbiome, pH and short/branched chain fatty acids in infants receiving extensively hydrolyzed formula, amino acid formula, or human milk through two months of age.
Trial report in BMC microbiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02500563 (Exploratory/Proof of Principle Microbiota Study), which is not on this map. Cited by 27 papers, 1 of them a synthesis 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.
Exploratory/Proof of Principle Microbiota Study
Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled 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
- An Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides Modifies the Fecal Microbiome and Metabolome in Infants with Cow's Milk Protein Allergy.International journal of molecular sciences · 2023Trial
- Probiotic supplementation in neonates with congenital gastrointestinal surgical conditions: a pilot randomised controlled trial.Pediatric research · 2022Trial
- Stool microbiome, pH and short/branched chain fatty acids in infants receiving extensively hydrolyzed formula, amino acid formula, or human milk through two months of age.BMC microbiology · 2020Trial
- Amino acid-based formula feeding is associated with increased risk ofGut microbes · 2026Article
- Feeding Type Shapes Infant Gut Microbiota and Metabolite Profiles in a Simulated Colonic Model.Microorganisms · 2026Article
- Influence of oropharyngeal therapy with mother's own milk on the microbiome and metabolome of very preterm infants: a pilot study.Frontiers in nutrition · 2025Article
- Dietary patterns influencing the human colonic microbiota from infancy to centenarian age: a narrative review.Frontiers in nutrition · 2025Review
- Gut microbiota and colorectal cancer: mechanistic insights, diagnostic advances, and microbiome-based therapeutic strategies.Frontiers in microbiology · 2025Review
- Effects of a specific synbiotic blend on fecal short-chain fatty acids and gut inflammation in cow's milk-allergic children receiving amino acid-based formula during early life: results of a randomized controlled trial (PRESTO study).Frontiers in allergy · 2025Article
- Iron Fortification and Inulin Supplementation in Early Infancy: Evaluating the Impact on Iron Metabolism and Trace Mineral Status in a Piglet Model.Current developments in nutrition · 2024Article
- Maternal-Foetal/Infant Interactions-Gut Microbiota and Immune Health.Biomedicines · 2024Review
- Alterations in the gut microbiota of toddlers with cow milk protein allergy treated with a partially hydrolyzed formula containing synbiotics: A nonrandomized controlled interventional study.Food science & nutrition · 2024Article
- Effect of protein modification in synbiotic infant formula on probiotic metabolic activity and bacterial composition in an infant gut-model.Microbiome research reports · 2024Article
- Gut microbiome derived short chain fatty acids: Promising strategies in necrotising enterocolitis.Current research in microbial sciences · 2024Article
- Supplementation of Heat-TreatedJournal of nutrition and metabolism · 2024Article
- Microbiota, metabolic profiles and immune biomarkers in infants receiving formula with added bovine milk fat globule membrane: a randomized, controlled trial.Frontiers in nutrition · 2024Article
- Investigating the properties and antibacterial, antioxidant, and cytotoxicity activity of postbiotics derived from Lacticaseibacillus casei on various gastrointestinal pathogens in vitro and in food models.GMS hygiene and infection control · 2024Article
- A Pilot Study Exploring Temporal Development of Gut Microbiome/Metabolome in Breastfed Neonates during the First Week of Life.Pediatric gastroenterology, hepatology & nutrition · 2023Article
- Review
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEarly infant feeding with intact or extensively hydrolyzed (EH) proteins or free amino acids (AA) may differentially affect intestinal microbiota composition and immune reactivity. This multicenter, double-blind, controlled, parallel-group, pilot study compared stool microbiota from Baseline (1-7 days of age) up to 60 days of age in healthy term infants who received mother's own milk (assigned to human milk [HM] reference group) (n = 25) or were randomized to receive one of two infant formulas: AA-based (AAF; n = 25) or EH cow's milk protein (EHF; n = 28). Stool samples were collected (Baseline, Day 30, Day 60) and 16S rRNA genes were sequenced. Alpha (Shannon, Simpson, Chao1) and beta diversity (Bray Curtis) were analyzed. Relative taxonomic enrichment and fold changes were analyzed (Wilcoxon, DESEq2). Short/branched chain fatty acids (S/BCFA) were quantified by gas chromatography. Mean S/BCFA and pH were analyzed (repeated measures ANOVA).
resultsAt baseline, alpha diversity measures were similar among all groups; however, both study formula groups were significantly higher versus the HM group by Day 60. Significant group differences in beta diversity at Day 60 were also detected, and study formula groups were compositionally more similar compared to HM. The relative abundance of Bifidobacterium increased over time and was significantly enriched at Day 60 in the HM group. In contrast, a significant increase in members of Firmicutes for study formula groups were detected at Day 60 along with butyrate-producing species in the EHF group. Stool pH was significantly higher in the AAF group at Days 30 and 60. Butyrate increased significantly from Baseline to Day 60 in the EHF group and was significantly higher in study formula groups vs HM at Day 60. Propionate was also significantly higher for EHF and AAF at Day 30 and AAF at Day 60 vs HM. Total and individual BCFA were higher for AAF and EHF groups vs HM through Day 60.
conclusionsDistinct patterns of early neonatal microbiome, pH, and microbial metabolites were demonstrated for infants receiving mother's own milk compared to AA-based or extensively hydrolyzed protein formula. Providing different sources of dietary protein early in life may influence gut microbiota and metabolites.
trial registrationClinicalTrials.gov Identifier: NCT02500563 . Registered July 28, 2015.
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.