Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD (FEMITGIGVHD)
Hematopoietic and Lymphoid Cell Neoplasm
About this trial
This is an interventional treatment trial for Hematopoietic and Lymphoid Cell Neoplasm focused on measuring allogeneic hematopoeitic stem cell transplantation, acute gastrointestinal graft versus host disease, fecal microbiome transplantation
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Shanghai Jiao Tong University Affilated First People's HospitalRecruiting
- Shanghai Jiao Tong University Affilated Shanghai General HospitalRecruiting
Arms of the Study
Arm 1
Experimental
fecal microbiome transplantation
Perform fecal microbiome transplantation to patient under colonoscopy or gastroscopy: injection of 200~300 ml fecal microbiome fluid as fecal microbiome transplantation to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy; If patient's condition is stable or improved within 1 week, second fecal microbiome transplantation may be performed 1 week later, up to 4 times will be performed if patient response; If patient's condition is not improved after the second fecal microbiome transplantation, stop fecal microbiome transplantation.