A Prospective Multicenter Randomized Controlled Trial Comparing Fecal Microbiota Transplantation (FMT) to Placebo in the Treatment of Mild to Moderate Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- Clinical and Endoscopic Remission
研究概览
简要总结
To determine the efficacy and safety of serial FMT at inducing and maintaining clinical and endoscopic response in patients with mild to moderate Crohn's disease
详细描述
Double blind study will randomize patients with mild to moderate Crohn's 1:1 (FMT : water) stratified by disease duration and current use of biologic therapy. First FMT/placebo at week 0 by colonoscopy plus weekly FMT/placebo by capsules for 7 weeks. At week 8, a repeat colonoscopy will be done and endoscopy score repeated.
Responders in FMT arm are eligible to enter open label phase to receive FMT by capsules q2 weeks.
Blood, stool and urine samples, colonic biopsies will be collected. Quality of Life as measured by Short Inflammatory Bowel Disease Questionnaire, EuroQol five dimensions, and Work Productivity and Activity Impairment Questionnaire: Crohns disease and dietary intake diary collected.
Colonoscopies recorded and reviewed by a central reader.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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
- •mild to moderate ileal, ileo-colonic or colonic Crohns disease
- •active ileal and/or colonic disease on endoscopy with or without elevated inflammatory markers i.e. C-reactive protein >8mg/L, elevated fecal calprotectin >250 ug/g
- •If applicable, meds stable as follows: 5-ASA for 4 weeks, prednisone up to 20mg QD for 4 weeks, budesonide up to 6mg QD for 4 weeks, azathioprine, 6-MP and methotrexate for 12 weeks
- •Use of effective contraception
排除标准
- •Antibiotic exposure within 30 days and probiotic exposure within 14 days
- •topical inflammatory bowel disease therapy within 2 weeks
- •active perianal disease
- •requirement for concurrent antibiotic therapy
- •SES-CD score <5
- •severe CD HBI >25 or need for hospitalization
- •abdominal abscess
- •extensive colonic resection, subtotal or total colectomy
- •ileostomy, colostomy, known fixed symptomatic stenosis or complex fistulae
- •evidence of or treatment for C. difficile or other intestinal pathogen including Cytomegalovirus within 28 days
- •requiring or expected to require surgical intervention
- •history or evidence of adenomatous colonic polyps not removed
- •history of evidence of colonic dysplasia
- •active substance abuse or psychiatric problems that may interfere with study
- •chronic Hep B, C, or HIV infection
- •pregnancy or planning to become pregnant
- •history of adhesions preventing colonoscopy to cecum
- •planned bowel resection within 3 mon of enrollment
结局指标
主要结局
Clinical and Endoscopic Remission
时间窗: Week 8
Harvey Bradshaw Index \<5 and Simple endoscopic score \<5
次要结局
- Clinical remission(Week 8)
- Quality of Life 3(Week 8)
- Quality of Life 2(Week 8)
- Endoscopic remission(Week 8)
- Clinical response(Week 8)
- Endoscopic response(Week 8)
- Quality of Life 1(Week 8)