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Recruiting Phase 3 NCT03819803

Fecal Microbiota Transplantation in aGvHD After ASCT

Trial Parameters

Condition Graft Versus Host Disease in GI Tract
Sponsor Medical University of Graz
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 15
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2017-03-01
Completion 2026-03-01
Interventions
Fecal microbiota transplantation

Brief 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.

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

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