A Clinical Study of Bacillus Coagulans in Acute Graft-Versus-Host Disease (aGVHD) After Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 508
- 主要终点
- Rate of acute graft-versus-host disease
研究概览
简要总结
To evaluate the preventive effect of Bacillus coagulans on acute graft-versus-host disease (aGVHD) after hematopoietic stem cell transplantation
详细描述
The study is conducted on patients after hematopoietic stem cell transplantation and the intervention is Bacillus coagulans, aiming to investigate the preventive effect of Bacillus coagulans on acute graft-versus-host disease after hematopoietic stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are fully aware of the study, voluntarily participate and sign informed consent;
- •Age: ≥18 years old;
- •Patients with hematologic malignancies undergoing allo-HSCT and patients with severe aplastic anemia (SAA) undergoing allo-HSCT were treated with myeloablative conditioning (MAC). lymphoma or multiple myeloma with auto-HSCT; multiple myeloma patients;
排除标准
- •Refused to participate in this clinical study;
- •Unable to take the drug orally;
- •Allergic to Bacillus coagulans;
- •People take allo-HSCT with reduced intensity conditioning (RIC) and nonmyeloablative conditioning (NMC);
研究组 & 干预措施
Experimental group
bacillus coagulans combined with the best treatment options for preventing aGVHD
干预措施: bacillus coagulans combined with the best treatment options for preventing aGVHD (Drug)
Control group
The best treatment options for preventing aGVHD
干预措施: BAT (Drug)
结局指标
主要结局
Rate of acute graft-versus-host disease
时间窗: 100th day
Will acute graft-versus-host disease occur within 100 days after hematopoietic stem cell transplantation and its probability of occurrence
次要结局
未报告次要终点
研究者
Yamin Fan
Chief Researcher
Wuhan Union Hospital, China