NCT06938165已完成不适用
The Safety and Efficacy of Fecal Microbiota Transplant for Steroid-refractory Graft-versus-host Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This clinical study evaluates the safety and efficacy of fecal microbiota transplantation (FMT) in patients with steroid-refractory graft-versus-host disease (GVHD).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to sign the informed consent form and complete follow-up;
- •Aged 18-65 years, regardless of gender;
- •Patients with refractory GVHD.
排除标准
- •life-threatening or associated with severe non-GvHD complications;
- •Persistent malignant conditions;
- •Patients who have undergone second or multiple hematopoietic stem cell transplants;
- •History of severe allergic reactions;
- •Any condition that the investigator considers unsuitable for inclusion (such as any history, treatment history, or abnormal test data that may confound the study results, interfere with full participation in the study, or harm the patient's interests);
研究组 & 干预措施
Patients with refractory graft-versus-host disease
Experimental
FMT for patients with refractory GVHD
干预措施: Fecal Microbiota Transplant (FMT) (Other)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 12 weeks
Assessment of ORR (ORR = Complete Response (CR) + Partial Response (PR)) at 12 weeks after treatment. CR was defined as the complete resolution of all disease manifestations in every affected organ or site. PR was defined as an improvement in at least one organ or site without any disease progression occurring in other organs or sites.
次要结局
- Number of Participants Experiencing an Adverse Event (AE)(12 weeks)
研究者
研究点 (1)
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