NCT06282952 Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation
| NCT ID | NCT06282952 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oulu University Hospital |
| Condition | Fecal Microbiota Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 534 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2031-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 534 participants in total. It began in 2026-03-31 with a primary completion date of 2031-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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). * Infant exclusion criteria are preterm birth (birth before 37 weeks of gestation), birth weight below 2500 g, admission to neonatal intensive care unit, need for respiratory support or antibiotic treatment of the newborn before discharge. In case of a suspected infection or newborn screening result for severe combined immunodeficiency (SCID) is out of the normal range, of the newborn the randomization code can be opened.
Contact & Investigator
Terhi Ruuska-Loewald, Professor
PRINCIPAL INVESTIGATOR
Oulu Univeristy Hospital
Frequently Asked Questions
Who can join the NCT06282952 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 49 Years, studying Fecal Microbiota Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06282952 currently recruiting?
Yes, NCT06282952 is actively recruiting participants. Contact the research team at marika.paalanne@oulu.fi for enrollment information.
Where is the NCT06282952 trial being conducted?
This trial is being conducted at Oulu, Finland.
Who is sponsoring the NCT06282952 clinical trial?
NCT06282952 is sponsored by Oulu University Hospital. The principal investigator is Terhi Ruuska-Loewald, Professor at Oulu Univeristy Hospital. The trial plans to enroll 534 participants.