Fecal Microbiota Transplant for Postoperative Crohn's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Ileal-associated microbiota engraftment
研究概览
简要总结
People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery.
This study aims to determine if fecal microbiota transplant (FMT) taken by capsules results in the same amount of good bacteria in the guts as FMT by colonoscopy in people with Crohn's disease who have had surgery.
Participants will be randomized to get FMT by capsules or colonoscopy. Colonoscopy with biopsies 8-weeks after the FMT will be used to assess the good bacteria in the gut.
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)
盲法说明
Placebo capsules are indistinguishable from study FMT capsules.
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
- •Able and willing to sign informed consent form
- •Age 18 or older
- •English speaking
- •Established CD for at least 6-months based on typical clinical, endoscopic, and histopathic evidence.
- •Prior ileocecal resection for CD
- •Stable medications for 30 days
- •Women of reproductive age: Agree to remain abstinent or use effective birth control
- •Able and willing to comply with all study procedures
排除标准
- •Antibiotic therapy within 15 days
- •Probiotic therapy within 15 days
- •Adenomatous polyps that have not been removed
- •Anticipated antibiotic use over the study period
- •Subtotal or total colectomy
- •Current ostomy (ileostomy or colonoscopy)
- •Anticipated surgical procedure over study period
- •Pregnancy
- •Severe food allergy
- •Diagnosis of end stage liver disease or cirrhosis
- •Absolute neutrophil count < 500 cell / uL
- •Life expectancy < 6 months
研究组 & 干预措施
Capsule fecal microbiota material (cap-FMT)
Participants will receive colonoscopy at day 0 and week 8 and receive cap-FMT orally for five days post-colonoscopy. Stool swabs and samples will be collected regularly.
干预措施: Capsule fecal microbiota material (cap-FMT) (Biological)
Colonoscopic fecal microbiota material (colo-FMT) plus placebo
Participants will receive colonoscopy at day 0 and week 8 and receive a placebo orally for five days post-colonoscopy. During the first colonoscopy, colo-FMT will be administered. Stool swabs and samples will be collected regularly.
干预措施: Colonoscopic fecal microbiota material (colo-FMT) (Biological)
结局指标
主要结局
Ileal-associated microbiota engraftment
时间窗: 8 weeks
Microbiota community of the ileum as sampled by ileal biopsies from colonoscopy. We will use SourceTracker, a Bayesian community-wide software, to assess composition and donor similarity.
次要结局
未报告次要终点