Status:
COMPLETED
Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Eligibility:
All Genders
14-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD...
Detailed Description
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD...
Eligibility Criteria
Inclusion
- Age\>= 14 yrs ≤60 yrs.
- Diagnosed with hematological diseases.
- Recipients of allogeneic peripheral blood stem cell transplantation.
- Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction.
- Eastern Cooperative Oncology Group (ECOG) score ≤2;
- Signed consent form.
Exclusion
- Complicated with uncontrolled severe infection except intestine and colon.
- High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;
- Absolute neutrophil count (ANC) \<0.5×10e9/L or platelet count (PLT) \< 20×10e9/L
- Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction.
- Participating other clinical trials.
- Pregnant women.
Key Trial Info
Start Date :
December 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03812705
Start Date
December 13 2018
End Date
April 15 2024
Last Update
April 23 2024
Active Locations (2)
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1
Shanghai Jiao Tong University Affilated First People's Hospital
Shanghai, Shanghai Municipality, China, 200080
2
Shanghai Jiao Tong University Affilated Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080