Clinical trial
Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation
Recruiting now · Not applicable · 1 countries · Registry ID NCT06282952
What this study is about
This single-center randomized controlled trial evaluates whether donor-derived fecal microbiota transplantation (FMT) administered within 6 hours after birth can improve gut microbiota development and reduce the risk of immune-mediated and metabolic diseases in infants born by elective cesarean delivery. Newborns are randomized 1:1 to receive either donor-derived FMT or standard postnatal care. Participants are followed through 36 months of age with stool samples, questionnaires, growth assessments, and health data collection, with registry-based follow-up continuing until 10 years of age.
Basic eligibility
Full registry criteria
Treatments and study arms
Donor-derived fecal microbiota transplantation
A fecal microbiota transplantation prepared from stool donated by a healthy female donor from the study microbiota bank is administered orally to the newborn within 6 hours after birth following elective cesarean delivery.
Primary outcomes
Incidence of a composite outcome including any autoimmune disease, allergic disease, obstructive respiratory disease requiring specialized healthcare, and overweight or obesity.
Study locations
1 locations were listed when this page was built. The first 40 are shown.