Skip to main content
Evidence-Based Supplement Research
Evidence-Based Supplement Research
Pillser
Search
Sign UpLog In

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

  • 2025-07-23
  • Frontiers in nutrition 12
    • Jean-Charles Picaud
    • Olivier Claris
    • Mercedes Gil-Campos
    • Ignacio Salamanca De La Cueva
    • Luc Cornette
    • Philippe Alliet
    • André Léké
    • Mireille Castanet
    • Hugues Piloquet
    • Virginie de Halleux
    • Delphine Mitanchez
    • Yvan Vandenplas
    • Pierre Maton
    • Frank Jochum
    • Dirk Olbertz
    • Sergio Negre Policarpo
    • Luca Lavalle
    • Cecilia Fumero
    • Paula Rodriguez-Garcia
    • Janne Marie Moll
    • Irma Silva-Zolezzi
    • Boutaina Zemrani
    • Nicholas P Hays
    • Norbert Sprenger
    • Javier Miranda-Mallea

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 313
Population
Healthy infants aged ≤14 days
Methods
Infants 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 weight gain velocity in SYN vs. CTRL through 4 months of age.

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 weight gain velocity in SYN vs. CTRL through 4 months of age. Secondary endpoints included fecal outcomes (abundance of bifidobacteria, immune and gut health markers), GI tolerance, and adverse events (AEs).

Results

The full analysis set (FAS) included 313 infants (118 in SYN, 114 in CTRL, and 81 BF), while the per-protocol population (PP) included 227 infants (84 in SYN, 84 in CTRL, and 59 BF). Weight gain velocity through 4 months in the SYN group was non-inferior to that in the CTRL group in both FAS and PP analyses (both p < 0.0001). Parent-reported GI tolerance and stool patterns were similar between SYN and CTRL groups through 4 months. At 3 months, Bifidobacteria abundance was significantly higher in the SYN group compared to the CTRL group (p = 0.004). Fecal pH was lower in the SYN group than in the CTRL group (p = 0.018) and more closely resembled that of the BF group. Immune and gut health markers were similar between the SYN and BF groups. No significant differences in AEs were observed across groups.

Conclusion

The synbiotic-supplemented infant formula supported healthy, age-appropriate growth, good GI tolerance, and increased the abundance of beneficial bifidobacteria through 4 months of age.

Clinical trial registration

https://clinicaltrials.gov/study/NCT04962594.

Research Insights

Back to top