Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- GI-aGvHD remission
研究概览
简要总结
Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients.
Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum.
Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first episode of histologically confirmed, steroid-refractory GI-aGvHD
- •reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement
- •eligibility for repeated colonoscopic procedures
- •informed consent
排除标准
- •complications during a previous colonoscopy
- •recurrent episode of GI-aGvHD
- •lacking cardiopulmonary fitness for repeated colonoscopic procedures
- •septic infection
- •acute extraintestinal organ failure (excluding bone marrow)
- •mechanical ileus
研究组 & 干预措施
Steroid refractory GI-aGvHD
Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids.
Intervention: Fecal microbiota transplantation
干预措施: Fecal microbiota transplantation (Biological)
结局指标
主要结局
GI-aGvHD remission
时间窗: 90 days after first FMT
Sustained remission of GI-aGvHD (CR or PR)
次要结局
- GI-aGvHD remission(45, 180 and 365 days after first FMT)
- Recurrence of GI-GvHD(365 days after remission)
- SAE (Serious Adverse Event)(within 48 hours after a FMT)
- SUSAR (Suspected Unexpected Serious Adverse Reaction)(within 48 hours after a FMT)
- Patient survival(180 and 365 days after first FMT)
- Disease-free survival(180 and 365 days after first FMT)