Safety of fecal microbiota transplantation for steroid-refractory/dependent acute graft-versus-host disease of the gut, a phase I trial
Not Applicable
Recruiting
- Conditions
- Steroid refractory/dependent acute graft-versus-host disease of gut after allogeneic hematopoietic stem cell transplantation or donor lymphocyte infusion
- Registration Number
- JPRN-UMIN000053473
- Lead Sponsor
- Hamanomachi hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1) Steroid sensitive aGVHD. 2) Progressive aGVHD, in which affected organ is irrelevant. 3) Uncontrollable infection. 4) Patients symptoms are considered to be caused mainly by enteropathy other than gut aGVHD. 5) PS 3 or higher. 6) Patients at high risk of aspiration. 7) Inadequate condition judged by primary physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of adverse events that occurred or worsened within 1 week after FMT
- Secondary Outcome Measures
Name Time Method