Maternal fecal transplant for babies born by cesarean section
Official title: Section-Born Infants and SUccessful Health Outcomes After Fecal Microbiota Transplantation (SISU-FMT)
Run by Oulu University Hospital · NCT06282952 · Data updated 2026-11-12
This trial will try giving a small fecal transplant from the mother to newborns delivered by elective C-section to see if it improves their gut microbiome and lowers the risk of later overweight or obesity.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Hours to 6 Hours |
| Sex | All |
| Enrollment | 460 (estimated) |
| Sponsor | Oulu University Hospital Academic / other |
| Locations | 1 site (Oulu) |
| Status | Recruiting |
| Started | March 31, 2026 |
| Main results expected | March 31, 2031 |
| Study ends | December 31, 2036 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT06282952 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women aged 18–49 scheduled for elective term cesarean delivery and their newborns, who meet the trial's medical and travel-related inclusion and exclusion criteria and can deliver and follow up at Oulu University Hospital.
✕Probably not a fit
Infants born preterm, with birth weight under 2500 g, admitted to the neonatal intensive care unit, or whose mothers have recent antibiotic use, inflammatory bowel disease, or immunodeficiency are unlikely to be eligible or to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Pregnant women scheduled for elective cesarean delivery at term are randomized to have their baby receive a maternal fecal microbiota transplant immediately after birth or not, with follow-up measurements of the infant gut microbiome, height, and weight. The study uses metagenomic sequencing and other microbiology methods to compare colonization patterns and quantify how much maternal microbes establish in the infant gut. Key exclusions include recent maternal antibiotic use, maternal inflammatory bowel disease or immunodeficiency, and infant outcomes such as preterm birth, low birth weight, or need for neonatal intensive care. The goal is to determine whether changing the early source of colonization can modify microbiota development and influence risk of overweight.
Why it matters
Potential benefit: If successful, the approach could help restore a more maternal-like gut microbiome in C-section babies and reduce their risk of becoming overweight or obese.
How similar studies have gone: Small pilot and observational studies have shown that maternal microbial transfer can partially restore the gut microbiota of C-section infants, but long-term effects on childhood weight and obesity prevention remain unproven.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Oulu University Hospital
Oulu, Finland Recruiting
Study contacts
- Principal investigator: Terhi Ruuska-Loewald, Professor — Oulu Univeristy Hospital
- Study coordinator: Marika Paalanne, MD, PhD
- Email: marika.paalanne@oulu.fi
- Phone: +358505794646
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.