Partially hydrolyzed, whey-based infant formula with six human milk oligosaccharides, <i>B. infantis</i> LMG11588, and <i>B. lactis</i> CNCM I-3446 is safe, well tolerated, and improves gut health: a staged analysis of a randomized trial.

ABSTRACT:

Background and aims

Gut health and microbiome development are closely linked in early life, with human milk oligosaccharides (HMOs) playing a key role. This study reports results through 4 months of age from a trial evaluating an infant formula containing a synbiotic blend of HMOs and probiotics, focusing on growth, gastrointestinal (GI) tolerance, and gut health biomarkers from birth to 15 months.

Materials and methods

Healthy infants aged ≤14 days were randomized to receive either the experimental formula (SYN; control formula supplemented with six HMOs and two probiotics [B. infantis, B. lactis]) or the control formula (CTRL; partially hydrolyzed 100% whey-based formula). A non-randomized breastfed (BF) group served as a reference. The primary endpoint was w

SUBMITTER: Picaud JC 

PROVIDER: S-EPMC12325064 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature