Summary
This multicentre RCT evaluated an infant formula supplemented with a five-component human milk oligosaccharide (HMO) blend in healthy neonates aged 7–21 days, comparing standard formula, two HMO-enriched formulations (1.5 and 2.5 g/L), and a human milk-fed reference group. Infants receiving HMO-supplemented formula developed microbiota compositions and gut maturation markers (higher Bifidobacterium, lower pathogenic Clostridioides difficile, improved immune markers) significantly closer to those of human milk-fed infants, suggesting the specific HMO blend may support healthy intestinal immune development in formula-fed infants.
Regional applicability
The study includes European recruitment sites and uses internationally standardised microbiological and immunological methodologies, making findings broadly applicable to United Kingdom infant nutrition practice. The HMO-supplemented formula approach aligns with established public health interest in closer alignment of formula composition with human milk; however, UK adoption would depend on regulatory approval, cost, and integration with existing infant feeding guidance.
Key measures
Shotgun metagenomics profiling of fecal microbiota; relative abundance of Bifidobacterium longum subsp. infantis and Clostridioides difficile; fecal pH and organic acid profiles; secretory immunoglobulin A (sIgA), alpha-1-antitrypsin, and calprotectin concentrations in fecal samples
Outcomes reported
The study measured gut microbiota composition, bacterial abundance, fecal metabolites, and intestinal biomarkers (sIgA, calprotectin, alpha-1-antitrypsin) in infants fed formula with added human milk oligosaccharides versus standard formula and human milk. Infants receiving HMO-supplemented formula showed microbiota profiles closer to human milk-fed infants, with increased beneficial Bifidobacterium and reduced toxigenic Clostridioides difficile.
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