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

What this Trial Is About

This research aims to evaluate the safety, feasibility, and potential effectiveness of fecal microbiota transplantation (FMT) for treating gastrointestinal symptoms in children and young adults who have undergone a hematopoietic cell transplant (HCT). It focuses on conditions like graft-versus-host disease (GvHD) of the gut and HCT-induced gut dysfunction, addressing significant digestive issues these patients may face after transplant. 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. If symptoms partially improve or remain unchanged, a second FMT can be given at least 14 days after the first, using the same procedures. The study includes two groups based on diagnosis: those with GvHD and those with gastrointestinal dysfunction. During the study, researchers will monitor participants for serious and non-serious adverse events within 30 days after FMT. They will also track enrollment rates, dropout rates, and stool sample collection over several years. Effectiveness will be assessed by measuring response rates up to 180 days and steroid reduction or discontinuation at one year. Participants will undergo scheduled assessments and provide stool samples to help evaluate treatment impact and safety throughout the study period, which may last up to three years.

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