Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation

NCT06282952 | Recruiting DMC

• 1 other identifier: 183/2026
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fecal Microbiota Transplantation; Cesarean Section; Overweight and Obesity

Keywords

Fecal Microbiota Transplantation; Cesarean Section; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Composite incidence of immune-mediated and metabolic disorders

  Incidence of a composite outcome including any autoimmune disease, allergic disease, obstructive respiratory disease requiring specialized healthcare, and overweight or obesity.

  Birth to 10 years of age

Secondary Outcomes (9)

• The source of colonization by exclusively shared genes (ESGs)

  3 month of age

• Microbial composition profiles in fecal sample

  Until 12 months of age

• Height in centimeters

  10 years of age

• Weight-for-length (%)

  10 years of age

• Weight in kilograms

  10 years of age

Study Arms (2)

Fecal microbiota transplant from biobank

EXPERIMENTAL

The newborns receive fecal microbiota transplant from their own mother (230 newborns).

Dietary Supplement: Donor-derived fecal microbiota transplantation

Controls

NO INTERVENTION

230 mothers and infants are recruited in no intervention group.

Interventions

Donor-derived fecal microbiota transplantation DIETARY_SUPPLEMENT

A fecal microbiota transplantation prepared from stool donated by a healthy female donor from the study microbiota bank is administered orally to the newborn within 6 hours after birth following elective cesarean delivery.

Fecal microbiota transplant from biobank

Eligibility Criteria

• Age: 0 Hours - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Oulu University Hospital: lead
• University of Oulu: collaborator
• University of Turku: collaborator
• Turku University Hospital: collaborator
• University of Helsinki: collaborator
• Academy of Finland: collaborator
• Biocenter Oulu: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, Finland

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Terhi Ruuska-Loewald, Professor

  Oulu Univeristy Hospital

  PRINCIPAL INVESTIGATOR

• Marika Paalanne, MD, PhD

  Oulu Univeristy Hospital

  STUDY DIRECTOR

Central Study Contacts

Marika Paalanne, MD, PhD

CONTACT

+358505794646; marika.paalanne@oulu.fi

Terhi Ruuska-Loewald, Professor

CONTACT

+358505794420; terhi.ruuska-loewald@oulu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The research statistician performs the computer-generated randomization. The study nurse prepares the fecal transplant according to the randomization. Study participants or investigators are not aware of study group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Model Details: Eligible newborns are randomized 1:1 using block randomization to receive either donor-derived fecal microbiota transplantation or standard postnatal care. The two groups are followed in parallel and compared with respect to microbiota development, growth, and health outcomes during childhood.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: February 28, 2024
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): December 31, 2036
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)