Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation

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

Interventions

DIETARY_SUPPLEMENT

Donor-derived fecal microbiota transplantation

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.

Sponsors & Collaborators

• University of Oulu

  collaborator OTHER

• University of Turku

  collaborator OTHER

• Turku University Hospital

  collaborator OTHER_GOV

• University of Helsinki

  collaborator OTHER

• Academy of Finland

  collaborator OTHER

• Biocenter Oulu

  collaborator UNKNOWN

• Oulu University Hospital

  lead OTHER

Principal Investigators

• Terhi Ruuska-Loewald, Professor · Oulu Univeristy Hospital

• Marika Paalanne, MD, PhD · Oulu Univeristy Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

0 Hours

Max Age

6 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2031-03-31

Completion

2036-12-31

Countries

• Finland

Study Locations