Related Experiment Video
Updated: Jul 21, 2025

Individualized Reconstitution of Human Milk Microbiota: A Feasible Approach in Real-World Settings
Published on: February 7, 2025
An Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides Modifies the Fecal Microbiome and
Claire L Boulangé1, Helle K Pedersen2, Francois-Pierre Martin1
1Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.
Insights
Human milk oligosaccharides (HMOs) in specialized infant formula enriched beneficial gut bacteria in infants with cow's milk protein allergy (CMPA). This supplementation helped normalize gut microbiome development, potentially improving infant health outcomes.
Area of Science:
- Pediatric Allergy and Immunology
- Gastroenterology
- Microbiome Research
Background:
- Cow's milk protein allergy (CMPA) is a common condition in infants, often associated with gut dysbiosis.
- The gut microbiome plays a crucial role in immune system development and overall infant health.
- Human milk oligosaccharides (HMOs) are known to modulate the infant gut microbiome.
Purpose of the Study:
- To investigate the impact of a whey-based extensively hydrolyzed formula (EHF) supplemented with specific HMOs (2'-FL and LNnT) on the fecal microbiome and metabolome of infants with CMPA.
- To assess whether HMO supplementation can correct gut dysbiosis in infants diagnosed with CMPA.
- To explore potential health benefits associated with HMO-mediated microbiome changes.
Main Methods:
- A randomized, multicenter intervention study involving 194 non-breastfed infants with CMPA.
- Fecal samples were collected at multiple time points (baseline, 1, 3 months, and 12 months of age).
- Analysis of fecal microbiome composition and metabolomic profiles to identify changes related to HMO supplementation.
Main Results:
- HMO supplementation significantly enriched Bifidobacteria in the infant gut microbiome.
- HMOs delayed the transition of the gut microbiome towards an adult-like composition.
- Specific changes in fecal amino acid degradation and bile acid conjugation were observed, particularly in infants starting supplementation before three months of age.
Conclusions:
- Supplementation with 2'-FL and LNnT in an EHF partially corrected gut dysbiosis in infants with CMPA.
- HMOs positively influence the gut microbiome composition and function in infants with CMPA.
- Further research is warranted to determine the clinical significance of these microbiome alterations, including potential reductions in infections.
Abstract:
Cow's milk protein allergy (CMPA) is a prevalent food allergy among infants and young children. We conducted a randomized, multicenter intervention study involving 194 non-breastfed infants with CMPA until 12 months of age (clinical trial registration: NCT03085134). One exploratory objective was to assess the effects of a whey-based extensively hydrolyzed formula (EHF) supplemented with 2'-fucosyllactose (2'-FL) and lacto-N-neotetraose (LNnT) on the fecal microbiome and metabolome in this population. Thus, fecal samples were collected at baseline, 1 and 3 months from enrollment, as well as at 12 months of age. Human milk oligosaccharides (HMO) supplementation led to the enrichment of bifidobacteria in the gut microbiome and delayed the shift of the microbiome composition toward an adult-like pattern. We identified specific HMO-mediated changes in fecal amino acid degradation and bile acid conjugation, particularly in infants commencing the HMO-supplemented formula before the age of three months. Thus, HMO supplementation partially corrected the dysbiosis commonly observed in infants with CMPA. Further investigation is necessary to determine the clinical significance of these findings in terms of a reduced incidence of respiratory infections and other potential health benefits.
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