Maternal fecal transplant for babies born by cesarean section

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 534 (estimated)
• Ages: 18 Years to 49 Years
• Sex: Female
• Sponsor: Oulu University Hospital (Academic / other)
• Locations: 1 site (Oulu)
• Trial ID: NCT06282952 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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.

Where this trial is running

Oulu

• Oulu University Hospital — Oulu, Finland (Recruiting)

Study contacts

• Principal investigator: Terhi Ruuska-Loewald, Professor — Oulu Univeristy Hospital
• Study coordinator: Marika Paalanne, MD, PhD

Conditions Fecal Microbiota Transplantation; Cesarean Section; Overweight and Obesity