Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation
Recruiting now · Not applicable
Conditions studied: Fecal Microbiota Transplantation, Cesarean Section, Overweight and Obesity
In brief
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.
Key facts
- Study ID
- NCT06282952
- Run by
- Oulu University Hospital
- People needed
- 460
- Starts
- 2026-03-31
- Expected to finish
- 2036-12-31
- Last updated by the study team
- 2026-07-21
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pregnant women aged 18 to 49 years Scheduled for elective cesarean delivery at term (≥37 completed weeks of gestation) Willing and able to provide written informed consent Infant eligible for study participation following birth
- Exclusion Criteria (Mother):
- Age <18 years or >49 years Multiple pregnancy Regular use of immunosuppressive biological medication Diagnosed immunodeficiency in the mother Diagnosed immunodeficiency in a first-degree relative of the unborn child Known or suspected major congenital structural anomaly in the fetus Known or suspected fetal immunodeficiency Previous participation in the SISU-FMT study
- Exclusion Criteria (Infant):
- Preterm birth (<37 completed weeks of gestation) Birth weight <2500 g Admission to a neonatal intensive care unit prior to the intervention Requirement for respiratory support prior to the intervention Requirement for systemic antibiotic treatment prior to the intervention
Where it is running
- Oulu University Hospital — Oulu, Finland (enrolling)
Full record on ClinicalTrials.gov
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