Status:
UNKNOWN
Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT
Lead Sponsor:
Qilu Hospital of Shandong University
Collaborating Sponsors:
Peking University People's Hospital
Conditions:
Acute Graft Versus Host Disease in Intestine
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients...
Detailed Description
Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), of which intestinal GVHD is a particularly serious one, which is the main c...
Eligibility Criteria
Inclusion
- received allo-HSCT due to a hematopoietic disease
- corticosteroid resistant/dependent intestinal GVHD
- ECOG≤2
- Sign informed Consent
- No major organ dysfunction
Exclusion
- uncontrolled or severe infections
- patients with severe liver and kidney function, cardiopulmonary insufficiency, epilepsy, and central nervous system disorder
- high-risk bleeding
- ANC\<0.5×10\^9/L or PLT\<20x10\^9/L
- hepatitis B, tuberculosis, syphilis, and HIV antibody positive or acute phase of any infectious disease
- patients participating in other clinical trials
- patienta who suffer from mental illness
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04711967
Start Date
March 10 2021
End Date
December 31 2023
Last Update
August 31 2021
Active Locations (2)
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1
Peking university people's hospital
Beijing, Beijing Municipality, China, 100044
2
Shandong university qilu hospital
Jinan, Shandong, China, 250012