Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD (NCT03812705) | Clinical Trial Compass
CompletedPhase 2
Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD
China6 participantsStarted 2018-12-13
Plain-language 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). The patient will cease antibiotics treatment 1 day before FMT, and stop taking food 6 hours before FMT. Patients will be given Ondansetron intravenously 1 hour before FMT. Patients will be injected 200\~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenal tube by gastroscopy. If patient's condition is stable or improved within 1 week, second FMT 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 FMT, ceasing FMT.
Who can participate
Age range14 Years – 60 Years
SexALL
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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;