Evaluating Safety and Potential Effectiveness of Fecal Microbiota Transplantation for Gut Problems in Children After Hematopoietic Cell Transplant

What this Trial Is About

This research evaluates the safety, feasibility, and potential effectiveness of fecal microbiota transplantation FMT for treating gastrointestinal complications in children following hematopoietic cell transplant HCT. The study focuses on participants who have gut graft-versus-host disease GvHD or prolonged gut dysfunction after HCT, aiming to understand how FMT may help these conditions. Participants will receive FMT starting at least 30 days after their transplant. The treatment involves administering 60 mL of microbiota preparation through a naso-enteral NJ tube and 250 mL via colonoscopy. A second FMT may be given at least 14 days after the first if symptoms have only partially improved or stayed the same, following the same administration procedure. During the study, participants will be monitored for adverse events up to 30 days after FMT and assessed for response to treatment over 180 days. Researchers will also track steroid use reduction and collect stool samples as part of the protocol. The study spans several years, with outcomes including safety, eligibility, recruitment, and treatment response being closely observed throughout the trial duration.

Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).