Vaginal microbiome seeding and health outcomes in Cesarean-delivered neonates: a randomized controlled trial

National Institute Of Allergy And Infectious Diseases

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Abstract

During the Fiscal Year 2025, the clinical trial continued enrollment and reached the end of Phase 1 of the study. A planned interim analysis is currently being conducted to investigate microbiome differences between the treatment and placebo arm. Initial early life microbiome data between treatment arms has been analyzed and shows a difference in microbiome structure and composition between treatment arms and that vaginal seeding causes engraftment of the maternal microbiome in multiple infant body sites in the first month of life. We are currently expanding this analysis to investigate the effects of vaginal seeding on transmission of bacteria and other microorganisms from mother to infant longitudinally and the effect on the infant metabolome. In addition, animal models of vaginal seeding using human samples from the trial transplanted to germ-free mice have shown 1) decreased intra-abdominal adiposity in the vaginally seeded group compared to controls and 2) differences in early life immune responses between the two groups.