Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm

Intervention / Treatment
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* Biological: fecal microbiome transplantation


Participation Criteria
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Eligibility Criteria
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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; 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: fecal microbiome transplantation for patients with steroid resistant/dependent acute gastroinstestinal graft versus host disease
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fecal microbiome transplantation<br>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. | Biological: fecal microbiome transplantation<br>* Stop antibiotics treatment 1 day before fecal microbiome transplantation; Fasting food 6 hours before fecal microbiome transplantation; Give Ondansetron intravenously 1 hour before fecal microbiome transplantation for vomiting prevention; Perform fecal microbiome transplantation under colonoscopy or gastroscopy; Perform up to 4 times if patient response; Stop if no response after twice fecal microbiome transplantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response. | 12 weeks within FMT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to response | Time to response of acute gastrointestinal GVHD | 12 weeks within FMT | 
| Duration of response | Duration of response of acute gastrointestinal GVHD | 12 weeks within FMT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allogeneic hematopoeitic stem cell transplantation, acute gastrointestinal graft versus host disease, fecal microbiome transplantation