Fecal Microbiota Transplantation for Treatment of Steroid Resistant Acute Graft Versus Host Disease of the Gut
Trial Snapshot
- Phase
- Early Phase 1
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Gut acute Graft-versus-Host Disease (aGvHD) response.
Study Overview
Brief Summary
The study aims to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of steroid resistant graft-versus-host-disease (GVHD) of the gut. This strategy might offer a safe and effective therapeutic approach for these patients with a poor prognosis and limited therapeutic options.
Detailed Description
Graft-versus-host-disease (GVHD) is a major complication after hematopoietic stem cell transplantation (HSCT). Gut is the most vulnerable target organ of acute GVHD. Patients who develope the acute gut GVHD and do not respond to the first line therapy with steroids have a high mortality. The investigation of safe and effective second line therapy for these patients are in need. The study evaluates safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of streoid resistant GVHD of the gut. Stool for FMT will be prepared from the healthy donor.This strategy might offer a safe and effective therapeutic approach for these acute steroid resistant gut GVHD patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. Adults(ages are elder than 18 years and younger than 75 years) who developed gut acute Graft-versus-Host Disease(aGVHD) after allogeneic hematopoietic stem cell transplantation(HSCT) and were resistant to a first line therapy with steroids.
- •2. patients who were diagnosed as Stage 3 or 4 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) with the symptoms such as diarrhea or abdominal pain.
- •3. Participants who accepted the FMT treatment.
- •Signature of informed and written consent by the subject.
Exclusion Criteria
- •1. patients who were diagnosed as Stage 1 or 2 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD)
- •patients with unstable vital signs or severe cardiac and pulmonary disorder.
- •patients who were failure to cooperate endoscopy examination.
- •patients who were younger than 18 years or pregnant.
- •patients who were poor compliance to FMT treatment.
- •patients who were not able to give informed consent.
Outcomes
Primary Outcomes
Gut acute Graft-versus-Host Disease (aGvHD) response.
Time Frame: 1 day to 7 days following FMT
Participants will be evaluated within 7 days following transplantation for response to therapy.
Secondary Outcomes
- Non-serious adverse events(1,3,5,7 days following FMTs)
- Change in microbiota composition after FMT(1,3,5,7 days months following FMT)
- Number of participants with infectious disorders(1,3,5,7 days following FMT)
- Number of multidrug resistant bacteria in faeces(1,3,5,7 days following FMT)
- aGvHD severity(1,3,5,7 days following FMT)