NCT02227342已完成1 期
A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis
适应症
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
- Mayo score reduction
研究概览
简要总结
Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for IBD 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 UC 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
same as above
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
- •Diagnosis of UC for > 3 months but < 5 years prior to screening as determined by the investigators
- •Those with mild to moderate UC
- •Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine or 6 mercaptopurine (6-MP) 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 or 6-MP must be at a stable dose for > 8 weeks
- •ability to provide informed consent
- •evidence of active inflammation
排除标准
- •Those whose disease is limited to the rectum (ie. proctitis)
- •Those with colectomy or diverting ileostomy
- •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 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
- •Those with colonic mucosal dysplasia
结局指标
主要结局
Mayo score reduction
时间窗: 12 and 32 weeks
Patients with at least 3 point reduction in partial Mayo scoring index 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
研究点 (1)
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