Fecal Microbiota Transplantation to Improve Health in Infants Born by Elective Cesarean Section A Randomized Study Following Participants to Age 10

What this Trial Is About

Researchers are evaluating whether giving donor-derived fecal microbiota transplantation FMT within 6 hours after birth can improve gut microbiota development and lower the risk of immune-related and metabolic diseases in infants born by elective cesarean delivery. This single-center randomized controlled trial enrolls newborns and follows them through early childhood and beyond to study these health outcomes. Newborns are randomly assigned to receive either an oral fecal microbiota transplant from a healthy female donor within 6 hours of birth or standard postnatal care without transplantation. The study excludes infants born preterm, with low birth weight, or requiring intensive care or antibiotics before intervention. Maternal eligibility criteria include age, pregnancy type, and absence of certain immunodeficiencies or anomalies. Participants are followed through 36 months with stool samples, questionnaires, growth checks, and health data from medical records. Long-term follow-up using national health registries continues until 10 years of age with parental consent. Researchers measure a combined outcome of autoimmune, allergic, respiratory diseases, and obesity, along with gut microbiota profiles and growth patterns to understand the impact of the transplantation.

Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation