Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation
Key facts
- Where
- Oulu, FinlandSee the site
Where in Finland
- Oulu University HospitalOulu, FinlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oulu University Hospital
- Trial code
- NCT06282952
- Record updated
- 21 July 2026
- Original description
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.Read full original descriptionShow less
Section-Born Infants and SUccessful Health Outcomes After Fecal Microbiota Transplantation (SISU-FMT)
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.
Inclusion: 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: 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.