Prospective Study of Fecal Microbiota Transplantation for Acute Intestinal GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- change in times of stool
研究概览
简要总结
Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients to demonstrate the efficacy and safety of FMT.
详细描述
Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), of which intestinal GVHD is a particularly serious one, which is the main cause of death after allo-HSCT. Recent studies have demonstrated that intestinal flora imbalance is strongly associated with the risk of infection and mortality in patients with allo-HSCT. On the basis of this theory, fecal microbiota transplantation (FMT) may be an effective method for GVHD, that is, fecal suspension from healthy individuals is inputted into the digestive tract of patients through some methods, so as to restore the microbial community diversity of patients. In this prospective study, the investigators aimed to demonstrate the efficacy and safety of this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •received allo-HSCT due to a hematopoietic disease
- •corticosteroid resistant/dependent intestinal GVHD
- •Sign informed Consent
- •No major organ dysfunction
排除标准
- •uncontrolled or severe infections
- •patients with severe liver and kidney function, cardiopulmonary insufficiency, epilepsy, and central nervous system disorder
- •high-risk bleeding
- •ANC<0.5×10^9/L or PLT<20x10^9/L
- •hepatitis B, tuberculosis, syphilis, and HIV antibody positive or acute phase of any infectious disease
- •patients participating in other clinical trials
- •patienta who suffer from mental illness
研究组 & 干预措施
Fecal Microbiota Transplantation group
treat with FMT
干预措施: Fecal Microbiota Transplantation (Biological)
Control group
treat with traditional medicine
干预措施: drug (Drug)
结局指标
主要结局
change in times of stool
时间窗: day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Change in times of stool per day within 28 days after FMT
change in volume of stool
时间窗: day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Change in volume of stool per day within 28 days after FMT
次要结局
- Change in life quality up to 28 days(day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.)