Fecal Microbiota Transplantation in aGvHD After ASCT

Recruiting now · Phase 3

Conditions studied: Graft Versus Host Disease in GI Tract

In brief

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.

Key facts

Study ID: NCT03819803
Run by: Medical University of Graz
People needed: 15
Starts: 2017-03-01
Expected to finish: 2026-12-31
Last updated by the study team: 2025-12-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz — Graz, Styria, Austria (enrolling)

Full record on ClinicalTrials.gov

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