NCT04745221招募中不适用
Efficacy and Safety of Autologous Fecal Bacteria Transplantation in Preventing Acute Graft Versus Host Disease After Haploidentical Hematopoietic Stem Cell Transplantation: a Multicenter, Open, Randomized Controlled Clinical Study
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Acute Graft-Versus-Host Disease
研究概览
简要总结
To evaluation the efficacy and safety of autologous fecal bacteria transplantation in preventing acute graft versus host disease after haploidentical hematopoietic stem cell transplantation. Bone marrow transplant patients were recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Haplo-HSCT patients; Bacteroidetes >0.1%; inverse Simpson diversity ≥2
排除标准
- •Gastrointestinal diseases；Age>60; or Age<10；Probiotics or prebiotics were taken before enrollment
研究组 & 干预措施
with auto-FMT
Experimental
The patients in the experimental group took autologous fecal bacteria capsule about 3 weeks after bone marrow transplantation.
干预措施: autologous fecal bacteria (Other)
empty capsule
No Intervention
The patients in this group took empty capsule about 3 weeks after bone marrow transplantation
结局指标
主要结局
Acute Graft-Versus-Host Disease
时间窗: 90 days after haploidentical hematopoietic stem cell transplantation
次要结局
- overall survival(90 days after haploidentical hematopoietic stem cell transplantation)
- Event free survival(90 days after haploidentical hematopoietic stem cell transplantation)
研究者
Qi Xiao-Fei
Principal Investigator
The First Affiliated Hospital of Soochow University
研究点 (1)
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