Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation
Recruiting · NCT06282952 · Interventional (participants receive a specific treatment) · Lead sponsor: Oulu University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Donor-derived fecal microbiota transplantation
What this trial 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.
Who can take part
Age range
0 Hours to 6 Hours
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Oulu University Hospital - Oulu, Finland