Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation
Section-Born Infants and SUccessful Health Outcomes After Fecal Microbiota Transplantation (SISU-FMT)
Oulu University Hospital
534 participants
Mar 31, 2026
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are: * Could micobiota transplant be used improve gut microbiota and prevent overweight or obesity. * Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant.
Eligibility
Inclusion Criteria1
- Pregnant women age 18-49 years who are scheduled for elective CS at term, are recruited at 36 weeks of gestation during a visit for the assessment of mode of delivery at Oulu university Hospital, Oulu, Finland.
Exclusion Criteria1
- Use of regular immunosuppressive biological medication; inflammatory bowel disease in the mother; immunodeficiency disorder of the mother or any first-degree family member of the unborn baby; known or suspected major fetal congenital abnormality; travel outside Europe, the United States, Canada, Japan, Australia, or New Zealand within the last three months; and antibiotic treatment within three months of delivery (excluding prophylactic cefuroxime - or an alternative in case of allergy - administered prior to the elective cesarean section).
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Interventions
At delivery, the microbiota transplant is thawed and 0.5 mL representing 3.5 mg of the mother's or donors' fecal sample is dissolved in 5 mL of the mother's own milk or when not available pasteurized bank milk. The sample is given orally to newborn infants as soon as possible but not later than 6 h of delivery and not later than two hours after defrosting.
Locations(1)
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NCT06282952