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RECRUITING Phase 3 ClinicalTrials.gov

Fecal Microbiota Transplantation in aGvHD After ASCT

Sponsor: Medical University of Graz • ClinicalTrials.gov ID: NCT03819803

Registry updated: 2026-10-16
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Description

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.

Interventions

  • Fecal microbiota transplantation (Biological)
    200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum

Eligibility criteria

Inclusion Criteria: * first episode of histologically confirmed, steroid-refractory GI-aGvHD * reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement * eligibility for repeated colonoscopic procedures * informed consent Exclusion Criteria: * complications during a previous colonoscopy * recurrent episode of GI-aGvHD * lacking cardiopulmonary fitness for repeated colonoscopic procedures * septic infection * acute extraintestinal organ failure (excluding bone marrow) * mechanical ileus

Conditions

Graft Versus Host Disease in GI Tract

Locations

  • Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz — Graz, Styria, Austria
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record