Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorOulu University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Microbiota transplant from mother

Treatment groups

534 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Oulu University Hospital

Lead sponsor

University of Oulu

Collaborator

University of Turku

Collaborator

Turku University Hospital

Collaborator

University of Helsinki

Collaborator

Academy of Finland

Collaborator

Biocenter Oulu

Collaborator