Clinical trial

Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation

Recruiting now · Not applicable · 1 countries · Registry ID NCT06282952

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age0 Hours to 6 Hours
SexAll
Healthy volunteersNot accepted
ConditionFecal Microbiota Transplantation, Cesarean Section, Overweight and Obesity

Full registry criteria

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

Treatments and study arms

Donor-derived fecal microbiota transplantation

Dietary Supplement

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.

Primary outcomes

Composite incidence of immune-mediated and metabolic disordersBirth to 10 years of age

Incidence of a composite outcome including any autoimmune disease, allergic disease, obstructive respiratory disease requiring specialized healthcare, and overweight or obesity.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Oulu University Hospital🇫🇮 Oulu, Finland