Status:
RECRUITING
Fecal Microbiota Transplantation in aGvHD After ASCT
Lead Sponsor:
Medical University of Graz
Conditions:
Graft Versus Host Disease in GI Tract
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 const...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03819803
Start Date
March 1 2017
End Date
December 31 2026
Last Update
December 2 2025
Active Locations (1)
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1
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz
Graz, Styria, Austria, 8036