Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-6
SponsorOulu University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Donor-derived fecal microbiota transplantation

Treatment groups

460 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Oulu University Hospital

Lead sponsor

University of Oulu

Collaborator

University of Turku

Collaborator

Turku University Hospital

Collaborator

University of Helsinki

Collaborator

Academy of Finland

Collaborator

Biocenter Oulu

Collaborator