Trial reportThe American journal of clinical nutrition2022
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.
Trial report in The American journal of clinical nutrition, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 5 of them syntheses that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
33 citing papers in PubMed, 5 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Difference in the Intestinal Microbiota between Breastfeed Infants and Infants Fed with Artificial Milk: A Systematic Review.Pathogens (Basel, Switzerland) · 2024Pooled it
- The Impact of Cesarean Section Delivery on Intestinal Microbiota: Mechanisms, Consequences, and Perspectives-A Systematic Review.International journal of molecular sciences · 2024Pooled it
- Impact of probiotic on anxiety and depression symptoms in pregnant and lactating women and microbiota of infants: A systematic review and meta-analysis.Journal of global health · 2023Pooled it
- Pooled it
- Pooled it
- Bifidogenic Effect of 2'-Fucosyllactose (2'-FL) on the Gut Microbiome of Healthy Formula-Fed Infants: A Randomized Clinical Trial.Nutrients · 2025Trial
- Gut microbiota translocation and dissemination in health: can it be beneficial and purposeful?Gut microbes · 2026Review
- Human Milk as a Model for Next-Generation Infant Formula: Opportunities and Challenges.Advances in nutrition (Bethesda, Md.) · 2026Review
- Dynamic Succession of the Early-Life Gut Microbiota and the Regulatory Role of Human Milk Oligosaccharides.Nutrients · 2026Review
- Natural and Biological Products Therapeutic Potential in Restoring Gut Microbiome: Mechanistic Insights and Clinical Implications.Probiotics and antimicrobial proteins · 2026Review
- Consequences of host-microbiome interactions in preterm infants.Infection and immunity · 2025Review
- Diet's impact on gut microbial assemblage in health and disease.The Journal of clinical investigation · 2025Review
- The Impact of Substance Use Disorder and Drug Transfer into Breast Milk: Implications for Maternal and Infant Health.Pharmaceutics · 2025Review
- Prebiotics and Probiotics Supplementation in Pigs as a Model for Human Gut Health and Disease.Biomolecules · 2025Review
- Resilience to Global Health Challenges Through Nutritional Gut Microbiome Modulation.Nutrients · 2025Review
- Geographic disparities impacting oral vaccine performance: Observations and future directions.Clinical and experimental immunology · 2025Review
- Recent advances in the science of human milk oligosaccharides.BBA advances · 2025Article
- Metabolic modulation and multi-species interaction:Frontiers in cellular and infection microbiology · 2025Article
- The importance of gut microbiome in the perinatal period.European journal of pediatrics · 2024Review
- Maternal-Foetal/Infant Interactions-Gut Microbiota and Immune Health.Biomedicines · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBovine milk-derived oligosaccharides (MOS) containing primarily galacto-oligosaccharides with inherent concentrations of sialylated oligosaccharides can be added to infant formula to enhance the oligosaccharide profile.
objectiveTo investigate the effects of an MOS-supplemented infant formula on gut microbiota and intestinal immunity.
methodsIn a double-blind, randomized, controlled trial, healthy term formula-fed infants aged 21-26 d either received an intact protein cow milk-based formula (control group, CG, n = 112) or the same formula containing 7.2 g MOS/L (experimental group, EG, n = 114) until the age of 6 mo. Exclusively human milk-fed infants (HFI, n = 70) from an observational study served as the reference. Fecal samples collected at baseline, and the ages of 2.5 and 4 mo were assessed for microbiota (16S ribosomal RNA-based approaches), metabolites, and biomarkers of gut health and immune response.
resultsAged 2.5 and 4 mo, redundancy analysis (P = 0.002) and average phylogenetic distance (P < 0.05) showed that the overall microbiota composition in EG was different from CG and closer to that of HFI. Similarly, EG caesarean-born infants were different from CG caesarean- or vaginally born infants and approaching HFI vaginally born infants. Relative bifidobacteria abundance was higher in EG compared with CG (P < 0.05) approaching HFI. At the age of 4 mo, counts of Clostridioides difficile and Clostridium perfringens were ∼90% (P < 0.001) and ∼65% (P < 0.01) lower in EG compared with CG, respectively. Geometric LS mean (95% CI) fecal secretory IgA in EG was twice that of CG [70 (57, 85) compared with 34 (28, 42) mg/g, P < 0.001] and closer to HFI. Fecal oral polio vaccine-specific IgA was ∼50% higher in EG compared with CG (P = 0.065). Compared with CG, EG and HFI had lower fecal calcium excretion (by ∼30%, P < 0.005) and fecal pH (P < 0.001), and higher lactate concentration (P < 0.001).
conclusionsInfant formula with MOS shifts the gut microbiota and metabolic signature closer to that of HFI, has a strong bifidogenic effect, reduces fecal pathogens, and improves the intestinal immune response.
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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.