Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Response rate
时间窗: 12 weeks within FMT
Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.
次要结局
- Duration of response(12 weeks within FMT)
- Time to response(12 weeks within FMT)
研究者
Liping Wan
Chief physician
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine