Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation

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.

NCT Number	NCT06282952
Lead Sponsor	Oulu University Hospital Collaborators: University of Oulu, University of Turku, Turku University Hospital, University of Helsinki, Academy of Finland, Biocenter Oulu
Conditions	Fecal Microbiota Transplantation, Cesarean Section, Overweight and Obesity
Enrollment	460 participants
Start Date	2026-03-31
Primary Completion	2031-03-31 (estimated)
Study Completion	2036-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-21