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Fecal Microbiota Transplantation for Steroid-Refractory Acute GI GVHD

StatusRecruiting
PhasePhase 2
Started2026-04-29
View on ClinicalTrials.gov ↗

Amendment history

2026-05-21
notable
Study Status, Contacts/Locations v1
Recruitment opened
Primary completion pushed: 2027-12-31 → 2028-02-28
Start dateestimated 2026-02-01→confirmed 2026-04-29
Study sites2→1
2026-01-16
minor
Original filing
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment for various hematologic diseases. However, one of the major challenges of allo-HSCT is the occurrence of graft-versus-host disease (GvHD), particularly acute gastrointestinal GvHD (GI-GvHD). GvHD occurs when donor T cells recognize the recipient's tissue as foreign and mount an immune attack against it. Acute GI-GvHD is a common complication following allo-HSCT and a significant cause of mortality. If the initial steroid treatment for acute GvHD fails, mortality rates can reach as high as 81%. Recent studies have shown a strong association between reduced gut microbiota diversity and high mortality in patients with acute GI-GvHD, highlighting the critical role of the gut microbiome in regulating immune responses and maintaining intestinal homeostasis. Consequently, fecal microbiota transplantation (FMT) has emerged as a potential therapeutic strategy aimed at restoring a healthy gut microbiome and improving clinical outcomes in patients with acute GI-GvHD. This study aims to evaluate the efficacy and safety of FMT in patients with steroid-refractory or steroid-resistant acute GI-GvHD. The findings of this research will contribute to establishing FMT as a potential and effective treatment option for managing severe acute GI-GvHD, thereby improving patient outcomes and reducing transplant-related mortality.
Trial Details
NCT Number NCT07364617
Lead Sponsor Chang Gung Memorial Hospital
Collaborators: National Taiwan University Hospital
Conditions Graft vs Host Disease
Enrollment 35 participants
Start Date 2026-04-29
Primary Completion 2028-02-28 (estimated)
Study Completion 2028-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-05-22