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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

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

534

Start Date

2026-03-31

Completion Date

2036-12-31

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Microbiota transplant from mother

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)

Oulu University Hospital

Oulu, Finland