A Synbiotic Infant Formula Promotes Balanced Immune-Microbiome Interactions in Term Infants: A Randomized Controlled Trial
Year: 2026
Type: preprint
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Formula-fed infants have altered gut microbiota and immune development relative to breastfed infants. Human milk oligosaccharides (HMOs) and microbes able to ferment these, like Bifidobacterium infantis, promote healthy immune-microbiome interactions in breastfed infants. In this randomized trial, 240 healthy term infants in the Philippines received a synbiotic formula (SynF; seven HMOs, bovine milk oligosaccharides, and B. infantis LMG11588) or control formula (CtrlF) for 6 months. SynF supported growth non-inferior to CtrlF and near universal B. infantis colonization ( vs <10% in CtrlF). Markers of intestinal inflammation were lower in children fed SynF while secretory IgA was higher. SynF fed infants showed lower markers of systemic inflammation in plasma, slower immune cell maturation, and fewer upper respiratory tract infections (URTI) during their first 6 months of life. These findings suggest that synbiotic formula can dampen inflammatory responses to colonizing microbes and mild infections in fully formula-fed, term infants. Trial registration: NCT06073652 .
Source: medRxiv
Authors: Qi Chen, Cheong Kwong Chung, Maria Rosario Z. Capeding, Mitzi Trinidad-Aseron, Vinna Marie R. Tenorio-Quiñones, Hugo Barcenilla, Laura Gonzalez, Anette Johnsson, Noura Darwish, Haolin Li, Jacob Agerbo Rasmussen, Janne Marie Moll, William Stauch, Jochen Schwenk, Tadepally Lakshmikanth, Norbert Sprenger, Nicholas P. Hays, Mario Noti, Petter Brodin
Institutions: Karolinska Institutet, Nestlé (Switzerland), Asian Hospital and Medical Center, University of Perpetual Help System DALTA, University of the East Ramon Magsaysay Memorial Medical Center, Science for Life Laboratory, KTH Royal Institute of Technology, Hammersmith Hospital, Imperial College London, Medical Research Council
Language: English
Topic: Infant Nutrition and Health
Subfield: Nutrition and Dietetics
Field: Nursing
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7221456289