Clinical Trial

Fecal Microbiota Transplantation in aGvHD After ASCT

Recruiting Phase 3
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Record status
This record was last updated December 2, 2025 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients. Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum. Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2019-01-24; most recent amendment 2025-11-24.
Trial Details
NCT Number NCT03819803
Lead Sponsor Medical University of Graz
Conditions Graft Versus Host Disease in GI Tract
Enrollment 15 participants
Start Date 2017-03-01
Primary Completion 2026-03-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-02