Fecal Microbiota Transplantation for Treatment of Steroid Resistant Acute Graft Versus Host Disease of the Gut
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gut acute Graft-versus-Host Disease (aGvHD) response.
研究概览
简要总结
The study aims to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of steroid resistant graft-versus-host-disease (GVHD) of the gut. This strategy might offer a safe and effective therapeutic approach for these patients with a poor prognosis and limited therapeutic options.
详细描述
Graft-versus-host-disease (GVHD) is a major complication after hematopoietic stem cell transplantation (HSCT). Gut is the most vulnerable target organ of acute GVHD. Patients who develope the acute gut GVHD and do not respond to the first line therapy with steroids have a high mortality. The investigation of safe and effective second line therapy for these patients are in need. The study evaluates safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of streoid resistant GVHD of the gut. Stool for FMT will be prepared from the healthy donor.This strategy might offer a safe and effective therapeutic approach for these acute steroid resistant gut GVHD patients.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adults(ages are elder than 18 years and younger than 75 years) who developed gut acute Graft-versus-Host Disease(aGVHD) after allogeneic hematopoietic stem cell transplantation(HSCT) and were resistant to a first line therapy with steroids.
- •2. patients who were diagnosed as Stage 3 or 4 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) with the symptoms such as diarrhea or abdominal pain.
- •3. Participants who accepted the FMT treatment.
- •Signature of informed and written consent by the subject.
排除标准
- •1. patients who were diagnosed as Stage 1 or 2 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD)
- •patients with unstable vital signs or severe cardiac and pulmonary disorder.
- •patients who were failure to cooperate endoscopy examination.
- •patients who were younger than 18 years or pregnant.
- •patients who were poor compliance to FMT treatment.
- •patients who were not able to give informed consent.
结局指标
主要结局
Gut acute Graft-versus-Host Disease (aGvHD) response.
时间窗: 1 day to 7 days following FMT
Participants will be evaluated within 7 days following transplantation for response to therapy.
次要结局
- Non-serious adverse events(1,3,5,7 days following FMTs)
- Change in microbiota composition after FMT(1,3,5,7 days months following FMT)
- Number of participants with infectious disorders(1,3,5,7 days following FMT)
- Number of multidrug resistant bacteria in faeces(1,3,5,7 days following FMT)
- aGvHD severity(1,3,5,7 days following FMT)