A Synbiotic Infant Formula Promotes Balanced Immune-Microbiome Interactions in Term Infants: A Randomized Controlled Trial
- 1Karolinska Institutet
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.
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BibTeX
@misc{chen2026synbiotic,
title = {{A Synbiotic Infant Formula Promotes Balanced Immune-Microbiome Interactions in Term Infants: A Randomized Controlled Trial}},
author = {Q. Chen and C. K. Chung and M. R. Z. Capeding and M. Trinidad-Aseron and V. M. R. Tenorio-Quinones and H. Barcenilla and L. Gonzalez and A. Johnsson and N. Darwish and H. Li and J. A. Rasmussen and J. M. Moll and W. Stauch and J. Schwenk and T. Lakshmikanth and N. Sprenger and N. P. Hays and M. Noti and P. Brodin},
howpublished = {medRxiv},
year = {2026},
month = oct,
doi = {10.64898/2026.10.05.26364773},
url = {https://www.medrxiv.org/content/10.64898/2026.10.05.26364773v1},
note = {CC BY-NC-ND},
}
RIS
TY - UNPB
TI - A Synbiotic Infant Formula Promotes Balanced Immune-Microbiome Interactions in Term Infants: A Randomized Controlled Trial
AU - Q. Chen
AU - C. K. Chung
AU - M. R. Z. Capeding
AU - M. Trinidad-Aseron
AU - V. M. R. Tenorio-Quinones
AU - H. Barcenilla
AU - L. Gonzalez
AU - A. Johnsson
AU - N. Darwish
AU - H. Li
AU - J. A. Rasmussen
AU - J. M. Moll
AU - W. Stauch
AU - J. Schwenk
AU - T. Lakshmikanth
AU - N. Sprenger
AU - N. P. Hays
AU - M. Noti
AU - P. Brodin
PY - 2026
DA - 2026/10/05
PB - medRxiv
DO - 10.64898/2026.10.05.26364773
UR - https://www.medrxiv.org/content/10.64898/2026.10.05.26364773v1
AB - 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.
ER -