Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Post-operative Endoscopic Recurrence
研究概览
简要总结
The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the risk of endoscopic recurrence of Crohn's disease (CD) in patients after intestinal resection. The specific outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical symptoms, 3) safety and tolerability, and 4) microbial diversity. The research team hypothesizes that FMT will prevent establishment of "pro-inflammatory" microbiome after surgery, leading to a reduced probability of recurrence of macroscopic inflammation. It is also hypothesized that FMT will be safe and well-tolerated in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
Post-operative Endoscopic Recurrence
时间窗: within 6 months of ileo-cecal resection
Percentage of patients in each arm of the trial who develop endoscopic recurrence within 6 months of ileo-cecal resection. "Endoscopic recurrence" will be defined as a Rutgeert's score of greater than i2
次要结局
- Adverse Events Frequency(4, 12, and 26 weeks)
- Change in Microbial Diversity: Shannon Diversity Index(baseline, 4, 12, and 26 weeks)
- Number of Participants in Clinical Remission at 26 Weeks(26 weeks)