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Sponsor: Oulu University Hospital
Conditions: Fecal Microbiota Transplantation, Cesarean Section, Overweight and Obesity
Interventions: Donor-derived fecal microbiota transplantation
Countries: Finland
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.
Sex: ALL
Age: 0 Hours to 6 Hours
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: 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
- Oulu, Finland