Trial reportNutrients2020
Early Effect of Supplemented Infant Formulae on Intestinal Biomarkers and Microbiota: A Randomized Clinical Trial.
Trial report in Nutrients, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05524649 (Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants), which is not on this map. Cited by 22 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.
Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.
- Effect of probiotic supplementation on the gut microbiota diversity in healthy populations: a systematic review and meta-analysis of randomised controlled trials.BMC medicine · 2026Pooled it
- Safety and Tolerance ofNutrients · 2025Trial
- Effect ofNutrients · 2023Trial
- Term infant formula supplemented with milk-derived oligosaccharides shifts the gut microbiota closer to that of human milk-fed infants and improves intestinal immune defense: a randomized controlled trial.The American journal of clinical nutrition · 2022Trial
- Unhealthy Diets, Unhealthy Futures: How Modern Eating Patterns Endanger Maternal and Offspring Health.Nutrients · 2026Review
- Article
- Human milkFrontiers in nutrition · 2025Review
- Early-life gut microbiome development and its potential long-term impact on health outcomes.Microbiome research reports · 2025Review
- Can Faecal Zonulin and Calprotectin Levels Be Used in the Diagnosis and Follow-Up in Infants with Milk Protein-Induced Allergic Proctocolitis?Nutrients · 2024Observational
- Two human milk-like synthetic bacterial communities displayed contrasted impacts on barrier and immune responses in an intestinal quadricellular model.ISME communications · 2024Article
- Pre-, pro-, syn-, and Postbiotics in Infant Formulas: What Are the Immune Benefits for Infants?Nutrients · 2023Review
- Faecal markers of intestinal inflammation in slum infants following yogurt intervention: A pilot randomized controlled trial in Bangladesh.Frontiers in microbiomes · 2023Article
- Infant feeding practice and gastrointestinal tolerance: a real-world, multi-country, cross-sectional observational study.BMC pediatrics · 2022Observational
- Review
- Infant nutrition affects the microbiota-gut-brain axis: Comparison of human milk vs. infant formula feeding in the piglet model.Frontiers in nutrition · 2022Article
- Neonatal Programming of Microbiota Composition: A Plausible Idea That Is Not Supported by the Evidence.Frontiers in microbiology · 2022Review
- Term Infant Formulas Influencing Gut Microbiota: An Overview.Nutrients · 2021Review
- Nurturing the Early Life Gut Microbiome and Immune Maturation for Long Term Health.Microorganisms · 2021Review
- The gut microbiota is associated with the small intestinal paracellular permeability and the development of the immune system in healthy children during the first two years of life.Journal of translational medicine · 2021Article
- Bovine Milk Oligosaccharides and Human Milk Oligosaccharides Modulate the Gut Microbiota Composition and Volatile Fatty Acid Concentrations in a Preclinical Neonatal Model.Microorganisms · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 6 institutions in 4 countries.
Funding
Abstract
backgroundPost-natal gut maturation in infants interrelates maturation of the morphology, digestive, and immunological functions and gut microbiota development. Here, we explored both microbiota development and markers of gut barrier and maturation in healthy term infants during their early life to assess the interconnection of gut functions during different infant formulae regimes.
methodsA total of 203 infants were enrolled in this randomized double-blind controlled trial including a breastfed reference group. Infants were fed starter formulae for the first four weeks of life, supplemented with different combination of nutrients (lactoferrin, probiotics (
resultsInfants fed formula containing BMOS had lower mean calprotectin levels over the first two to four weeks compared to the other formula groups. Elastase and AAT levels were closer to levels observed in breastfed infants. No differences were observed for neopterin. Global differences between the bacterial communities of all groups were assessed by constrained multivariate analysis with hypothesis testing. The canonical correspondence analysis (CCA) at genus level showed overlap between microbiota profiles at one and four weeks of age in the BMOS supplemented formula group with the breastfed reference, dominated by bifidobacteria. Microbiota profiles of all groups at four weeks were significantly associated with the calprotectin levels at 4 (CCA,
conclusionA meaningful correlation was observed between changes in microbiota composition and gut maturation marker calprotectin. The supplementation with BMOS seems to favor gut maturation closer to that of breastfed infants.
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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.