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RECRUITING
NCT06282952
NA

Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation

Sponsor: Oulu University Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Section-Born Infants and SUccessful Health Outcomes After Fecal Microbiota Transplantation (SISU-FMT)

Key Details

Gender

All

Age Range

0 Hours - 6 Hours

Study Type

INTERVENTIONAL

Enrollment

460

Start Date

2026-03-31

Completion Date

2036-12-31

Last Updated

2026-07-21

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Donor-derived fecal microbiota transplantation

A fecal microbiota transplantation prepared from stool donated by a healthy female donor from the study microbiota bank is administered orally to the newborn within 6 hours after birth following elective cesarean delivery.

Locations (1)

Oulu University Hospital

Oulu, Finland