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).~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.~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.~Treatment:~Stop antibiotics treatment 1 day before FMT;~Fasting food 6 hours before FMT;~Give Ondansetron intravenously 1 hour before FMT for vomiting prevention;~Injection of 200~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenum 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, stop FMT.~Major endpoint Response rate of acute gastrointestinal GVHD with 12 weeks after FMT, including complete response and partial response.~Minor endpoints:~Time to response of acute gastrointestinal GVHD;~Duration of response of acute gastrointestinal GVHD.
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.