NCT06282952Recruiting
Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation
Section-Born Infants and SUccessful Health Outcomes After Fecal Microbiota Transplantation (SISU-FMT)
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 460 (estimated)
- First submitted
- 16 Oct 2023
- Start date
- 31 Mar 2026
- Primary completion date
- 31 Mar 2031
- Lead sponsor
- Oulu University Hospital
- Diseases
- Obesity
- NCT number
- NCT06282952
What you commit to
- Study type: Interventional
- Planned participants: 460
- From 31 Mar 2026 to the primary completion date, 31 Mar 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 0 hours to 6 hours · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.