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
- 2
- 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
- •(Patients):
- •Adults (age > 18)
- •Confirmed diagnosis of Crohn's disease (CD), based on endoscopy, histology and imaging (confirmed by Study PI for each site)
- •Ileo-cecal resection or terminal ileal resection for CD within 30 days prior to enrollment
- •Resection margins & anastomosis free of active inflammation based on histology and surgical description (confirmed by Study PI for each site)
- •No therapy to prevent post-operative recurrence of CD. A 30-day wash-out period for anti- tumor necrosis factors (TNF)s, thiopurines, antibiotics will be required prior to enrollment.
排除标准
- •(Patients):
- •Diagnosis of indeterminate colitis
- •Women who are pregnant or nursing
- •Patients who are unable to give informed consent
- •Patients who are unable or unwilling to undergo colonoscopy with moderate sedation (>ASA class II)
- •Patients who have previously undergone FMT
- •Patients who have a confirmed malignancy or cancer
- •Participation in a clinical trial in the preceding 30 days or simultaneously during this trial
- •Probiotic use within 30 days of start date
- •Decompensated cirrhosis
- •Congenital or acquired immunodeficiencies
- •Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 44
- •History of rheumatic heart disease, endocarditis, or valvular disease due to risk of bacteremia from colonoscopy
研究组 & 干预措施
Fecal Microbiota Transplant (FMT)
Fecal Microbiota Transplant (FMT) via colonoscopy
干预措施: Fecal Microbiota Transplant (FMT) (Biological)
Control
No Fecal Microbiota Transplant (FMT) via colonoscopy
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)