NEwborn Infant of a Mother With Obesity - Fecal Microbiome Transplantation, RCT

Launched by OULU UNIVERSITY HOSPITAL · Feb 20, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how a treatment called fecal microbiota transplantation (FMT) can help improve the gut health of newborns. Specifically, it focuses on infants born by cesarean section to mothers who are overweight or obese. Researchers want to find out if FMT can change the gut bacteria in these babies and possibly prevent them from becoming overweight or obese as they grow. They are also looking into whether changing the source of the bacteria through FMT right after birth can make a difference.

To participate in this trial, mothers need to be between 18 and 49 years old, have obesity before pregnancy, and be scheduled for a planned cesarean section at a hospital in Oulu, Finland. Unfortunately, some mothers and infants may not be eligible due to certain health conditions or recent treatments. If a mother qualifies and decides to take part, she can expect to be involved in a study that aims to improve future health outcomes for her baby. The trial is not yet recruiting participants, so more information will be available soon.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant women age 18-49 years with obesity (prepregnancy BMI ≥ 30 kg/m2) 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.
• Exclusion Criteria:
• • Use of regular immunosuppressive biological medication, immunodeficiency disorder of mother or other first degree family member of the unborn baby, known or suspected fetal major congenital abnormality, travelling abroad outside European countries or United States within the last three months and antibiotic treatment within 3 months of delivery (excluding the prophylactic cefuroxime (or other in case of allergy) given prior to the elective CS).
• • 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.