Fecal Microbiota Transplantation in aGvHD After ASCT
Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation
Medical University of Graz
15 participants
Mar 1, 2017
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria6
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03819803