Status:
UNKNOWN
FMT for Steroid Resistant Gut Acute GVHD
Lead Sponsor:
Affiliated Hospital to Academy of Military Medical Sciences
Collaborating Sponsors:
Beijing 302 Hospital
Conditions:
Stem Cell Transplant Complications
Acute Graft-Versus-Host Disease
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
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 off...
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 gu...
Eligibility Criteria
Inclusion
- 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. 4. Signature of informed and written consent by the subject.
Exclusion
- 1\. patients who were diagnosed as Stage 1 or 2 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) 2. patients with unstable vital signs or severe cardiac and pulmonary disorder. 3. patients who were failure to cooperate endoscopy examination. 4. patients who were younger than 18 years or pregnant. 5. patients who were poor compliance to FMT treatment. 6. patients who were not able to give informed consent.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04285424
Start Date
March 1 2020
End Date
March 1 2022
Last Update
March 2 2020
Active Locations (1)
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1
Affiliated Hospital to Academy of Military Medical Sciences
Beijing, Beijing Municipality, China