Flourish Study: A Randomized, Three-Arm Longitudinal Clinical Study of Microbiome-Guided Interventions in Cesarean-Born Infants

What this Trial Is About

This research aims to find out if analyzing the gut microbiome, providing education, and offering personalized advice can improve gut health and reduce early signs of immune-related conditions in infants aged 0 to 3 months born by Cesarean section. The study focuses on whether these approaches can increase helpful bacteria, lower specific microbiome patterns linked to C-section births, reduce harmful microbes, and improve the gut's ability to digest human milk oligosaccharides and produce short-chain fatty acids. It also examines if these changes relate to fewer early atopic symptoms like eczema. Participants are divided into three groups: one receiving full intervention with detailed microbiome reports, coaching, personalized recommendations, and educational emails; a second group receiving simpler reports and basic probiotic advice with optional interpretation calls; and a control group that provides samples but does not receive results until the study ends. Over 24 months, participants provide six stool samples for microbiome analysis and additional samples for exploratory study. The full intervention group also receives scheduled remote consult calls, while the limited group can choose a call with a nurse for report review. Throughout the study, participants complete surveys about the infant's health, diet, and environment. Eczema assessments are done by a nurse and reviewed by a pediatric allergy specialist if symptoms appear. Researchers measure microbiome composition, specific microbial signatures, functional capacity related to digestion and fermentation, and eczema occurrence at 24 months. This study aims to show how tailored microbiome support might positively influence gut development in C-section infants and reduce risks linked to early allergic conditions.

Flourish: Exploring the Early Infant Gut Microbiome