Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation

Who is this study for? Patients with Graft versus Host Disease
What treatments are being studied? Fecal Microbiota Transplantation
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz
RECRUITING
Graz
Contact Information
Primary
Walter DDr. Spindelboeck
walter.spindelboeck@medunigraz.at
0043 316 385 30195
Time Frame
Start Date: 2017-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 15
Treatments
Experimental: Steroid refractory GI-aGvHD
Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids.~Intervention: Fecal microbiota transplantation
Sponsors
Leads: Medical University of Graz

This content was sourced from clinicaltrials.gov

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