Actively Recruiting

Phase Not Applicable
Age: 18Years - 49Years
FEMALE
NCT06282952

Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation

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

534

Participants Needed

1

Research Sites

561 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

The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are: * Could micobiota transplant be used improve gut microbiota and prevent overweight or obesity. * Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant.

CONDITIONS

Official 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 at Oulu University Hospital, Finland
Not Eligible

You will not qualify if you...

  • Regular use of immunosuppressive biological medication
  • Mother has inflammatory bowel disease
  • Immunodeficiency disorder in 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
  • Antibiotic treatment within three months of delivery (except prophylactic cefuroxime or alternative before elective cesarean section)
  • Infant born preterm (before 37 weeks gestation)
  • Infant birth weight below 2500 grams
  • Infant admitted to neonatal intensive care unit
  • Infant requires respiratory support or antibiotic treatment before discharge
  • Suspected infection or abnormal newborn screening result for severe combined immunodeficiency (SCID)

AI-Screening

AI-Powered Screening

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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

CONTACT

T

Terhi Ruuska-Loewald, Professor

CONTACT

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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