Actively Recruiting

Phase Not Applicable
Age: 18Years - 49Years
FEMALE
ID06282952

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

Led by Oulu University Hospital · Updated on 2026-04-07

534

Participants Needed

1

Research Sites

300 weeks

Total Duration

On this page

Sponsors

O

Oulu University Hospital

Lead Sponsor

U

University of Oulu

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates differences in gut microbiota, height, and weight between infants born by cesarean section who receive a fecal microbiota transplant shortly after birth. The study aims to find out whether microbiota transplant can improve gut bacteria and help prevent overweight or obesity, and whether the source of gut colonization is a changeable factor. The trial focuses on newborns of mothers undergoing elective cesarean section and explores early-life microbiota restoration and its potential long-term health effects. Newborns in the study are randomly assigned to one of three groups: receiving a fecal microbiota transplant from their own mother, from a healthy donor female from a microbiome biobank, or no intervention. The fecal transplant is prepared from fresh maternal or donor stool, screened for infections, and given orally to the infant within six hours of birth. Mothers and infants undergo sample collection and monitoring during hospital stay and follow-up, including stool samples, blood tests, questionnaires, and health data collection up to 10 years of age. Participants are followed closely with stool microbiota analyses at birth, 3 months, and 12 months, along with growth measurements at 10 years. Blood samples from infants are analyzed for immune and inflammatory markers early on. Parents provide health and nutrition information via online questionnaires. Safety monitoring includes tracking any adverse events in newborns during hospital stay. The study collects detailed data on infant growth, microbiota composition, and source of colonization, aiming for a comprehensive understanding of the effects of fecal transplant after cesarean birth.

CONDITIONS

Brief Title

Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation

Who Can Participate

Age: 18Years - 49Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women aged 18 to 49 years scheduled for elective cesarean section at term
  • Recruitment occurs at 36 weeks of gestation during a delivery mode assessment visit
Not Eligible

You will not qualify if you...

  • Use of regular immunosuppressive biological medication
  • Inflammatory bowel disease in the mother
  • Immunodeficiency disorder in 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 3 months
  • Antibiotic treatment within 3 months of delivery (excluding prophylactic cefuroxime or allergy alternative before cesarean section)
  • Infant born before 37 weeks gestation (preterm birth)
  • Infant birth weight below 2500 g
  • Infant admission to neonatal intensive care unit
  • Infant need for respiratory support or antibiotic treatment before hospital discharge
  • Suspected infection or abnormal newborn screening for severe combined immunodeficiency (SCID) in the infant
  • Randomization may be opened if newborn screening is out of normal range

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) around 10-14 days before scheduled cesarean section for sample collection and testing

Treatment

Duration - Single administration at birth

Participants receive a fecal microbiota transplant orally within 6 hours after delivery to modify the infant's gut microbiota.

1 visit at delivery (in-person)

Post-operative Follow-up

Duration - Up to 2 days (hospital stay post-delivery)

Participants are monitored during the hospital stay, including sample collection from the infant's first stool and clinical assessments before discharge.

Approximately 2 visits during hospital stay

Long-term Monitoring

Duration - Up to 12 months postnatally

Participants are followed in well-baby clinics according to normal national protocols with additional microbiota sample collections and questionnaires at 3 and 12 months postnatally.

2 main follow-up contacts: online questionnaires and fecal sample collections at 3 and 12 months

Trial Site Locations

Total: 1 location

1

Oulu University Hospital

Oulu, Finland

Actively Recruiting

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Research Team

M

Marika Paalanne, MD, PhD

T

Terhi Ruuska-Loewald, Professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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