Treatment of Steroid-Refractory Acute Gastrointestinal Graft-Versus-Host Disease Using Fecal Microbiota Transplantation After Allogeneic Stem Cell Transplant

What this Trial Is About

Researchers are studying a treatment for patients who have severe acute gastrointestinal graft-versus-host disease GI-GvHD that does not respond to steroids after receiving allogeneic hematopoietic stem cell transplantation allo-HSCT. This condition occurs when donor immune cells attack the patients gut, leading to serious health problems and high mortality rates. The study focuses on fecal microbiota transplantation FMT, which aims to restore a healthy gut microbiome, potentially improving immune balance and patient outcomes. Participants will receive 250 mL of microbiota fluid from healthy donors, delivered directly into the gut either to the terminal ileum or cecum via ileocolonoscopy, or to the duodenum via panendoscopy. After the first FMT, a second dose will be given 7 to 21 days later, with an optional third dose based on how well the patient responds. This is a phase II, single-arm, open-label trial enrolling 35 adults over two years to evaluate safety and effectiveness. During the study, patients will be monitored for event-free survival up to six months, response rates at 28 and 56 days after the first FMT, and overall survival over at least two years. Researchers will also track steroid use, adverse events, and changes in gut microbiology and immune markers. Follow-up assessments will include clinical evaluations and laboratory tests to measure treatment impact and safety throughout the trial period.

Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD