A Prospective Randomized Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT (Fecal Microbiota Transplantation) for Recurrent Clostridium Difficile Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 7
- 主要终点
- The evaluation of the safety of HBT
研究概览
简要总结
The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh FMT versus frozen-and-thawed FMT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of FMT and to compare the clinical response, treatment failure and relapse rate in patients treated with fresh FMT compared to those treated with frozen-and-thawed FMT; also to assess the functional health and well-being of patients in each arm using a validated tool. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The evaluation of the safety of HBT
时间窗: 13 Weeks post HBT
Assessment for adverse reactions in each study group by history, physical examination, blood work at baseline, day 12, week 5 and at completion (week 13) of the study period.
To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT.
时间窗: 13 Weeks post HBT
次要结局
- To determine the relapse rate of clinical and laboratory evidence of CDI within the 13-week study period in participants treated with fresh HBT in comparison to frozen thawed HBT.(13 Weeks post HBT)
- Assessment of the functional health and well-being of patients(Up to 1 year)