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Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation
Sponsor: Oulu University Hospital
Summary
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.
Official title: Section-Born Infants and SUccessful Health Outcomes After Fecal Microbiota Transplantation (SISU-FMT)
Key Details
Gender
All
Age Range
0 Hours - 6 Hours
Study Type
INTERVENTIONAL
Enrollment
460
Start Date
2026-03-31
Completion Date
2036-12-31
Last Updated
2026-07-21
Healthy Volunteers
No
Interventions
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.
Locations (1)
Oulu University Hospital
Oulu, Finland