A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Remission of UC
研究概览
简要总结
The goal of this study is to establish the safety and effectiveness of lyophilized (LYO) fecal microbiota transplant (FMT) for treating ulcerative colitis (UC) in adults. The protocol is being re-designed to address relevant, current research questions in the context of FMT treatment for UC. Once a final protocol is approved, this webpage will be updated.
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
- Triple (Participant, Care Provider, Investigator)
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 to provide informed consent.
- •Willing and able to comply with all the required trial procedures
- •Active ulcerative colitis as defined by Mayo score > 3 AND Mayo endoscopic sub-score > 1 (within 30 days before enrollment, or at baseline)
排除标准
- •Planned or actively taking another investigational product
- •Abdominal surgery within the past 60 days
- •Patients with neutropenia with absolute neutrophil count <0.5 x 109/L at - Evidence of toxic megacolon or gastrointestinal perforation on imaging
- •Peripheral white blood cell count > 35.0 x 109/L at enrollment AND temperature > 38.0oC
- •Active infectious diarrhea at the time of enrolment
- •Increase in medical therapy for UC within 3 months of enrollment. Continued treatment with stable dose of 5-ASA, azathioprine, 6-mercaptopurine, cyclosporine, prednisone and/or anti- TNF agents for at least 3 months of is allowed
- •Severe UC requiring hospitalization at the time of enrolment
- •Pregnant or lactating
- •History of anaphylaxis to any food
- •Requiring oral and/or intravenous systemic antibiotic therapy at the time of study enrolment
- •Unwilling to discontinue probiotic (yogurt is allowed)
- •Severe underlying disease such that the patient is not expected to survive for at least 30 days.
- •Any condition that in the opinion of the investigator that would pose harm to the participant or the research staff for the potential participant to take part in the trial
研究组 & 干预措施
Placebo oral & enema
twice weekly x 8 weeks: 10 placebo oral capsules + placebo enema
干预措施: Placebo oral (Other)
Placebo oral & enema
twice weekly x 8 weeks: 10 placebo oral capsules + placebo enema
干预措施: Placebo enema (Other)
LYO-FMT oral + placebo enema
twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 placebo enema
干预措施: FMT oral (Biological)
LYO-FMT oral + placebo enema
twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 placebo enema
干预措施: Placebo enema (Other)
LYO-FMT oral + LYO-FMT enema
twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 LYO-FMT enema
干预措施: FMT oral (Biological)
LYO-FMT oral + LYO-FMT enema
twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 LYO-FMT enema
干预措施: FMT enema (Biological)
结局指标
主要结局
Remission of UC
时间窗: 9 weeks following receipt of LYO-FMT
achievement of remission of UC as defined by Mayo score ≤ 2 AND Mayo endoscopic score of ≤ 1
次要结局
- Incidence/absence of adverse events upon treatment with LYO-FMT [safety and tolerability](up to 5 years post-FMT)
- UC disease progression(immediately after FMT (study) treatment period up to 5 years post-FMT)
研究者
Theodore Steiner
MD, Professor
University of British Columbia