A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Crohn's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- HBI score reduction
研究概览
简要总结
Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for CD patients. Studies are now required to determine if repeated FMT can overcome the apparent immune response to FMT thereby maintaining sustained clinical improvement and remission. Prior to a large randomized controlled trial of FMT in CD we will carry out a feasibility study to determine if serial FMTs can sustain a clinical response and maintain stability of transplanted microbiota.
详细描述
Participants receive FMT by colonoscopy at Weeks 0, 4, 8 and by enema at Weeks 2 and 6. Assessments include HBI score, SES-CD score, and serum CRP levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and < 65 years at the time of screening
- •Diagnosis of ileo-colonic or colonic CD for > 3 months but < 5 years prior to screening as determined by the investigators
- •Those with mild to moderate CD
- •Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine, 6 mercaptopurine (6-MP) or methotrexate for > 3 months
- •Where applicable, those who are taking the following medications must be at a stable dose defined as:
- •i) 5-ASA must be at a stable dose for 2 weeks ii) Prednisone up to 20 mg/d must be at a stable dose for 2 weeks iii) Budesonide up to 6 mg/d must be at a stable dose for 2 weeks iv) Azathioprine, 6-MP, and methotrexate must be at a stable dose for > 8 weeks
- •ability to provide informed consent
- •evidence of active colonic inflammation
排除标准
- •Those with prior ileo-cecal resection
- •Those who are pregnancy or plan to be pregnant during the trial
- •Those who are breastfeeding or plan to breast feed during the trial
- •Those who are on or have previously failed a biological agent
- •Those who have active perianal disease as determined by investigators
- •Those with an active infection requiring antibiotic therapy
- •Those with positive stool cultures for known pathogens such as E coli, Salmonella, Shigella, Yersinia, Campylobacter, and Clostridium difficile toxin within 2 weeks of enrollment
- •Those with positive CMV on colonic tissue biopsy within 2 weeks of screening
- •Those with allergy to ciprofloxacin and metronidazole
结局指标
主要结局
HBI score reduction
时间窗: 12 and 32 weeks
Patients with at least 3 point reduction in HBI scores at week 12 and at week 32 in the extension phase.
次要结局
未报告次要终点
研究者
Dina Kao
Associate professor
University of Alberta