Screening Donors for a Fecal Microbiota Transplant Program in Ulcerative Colitis: Evaluating Efficacy and Long-term Effects. the FUEL Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Efficacy of FMT donors at inducing UC remission
研究概览
简要总结
The investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. It is important to give UC patients participating in RCTs stool that has been demonstrated to be effective in some patients. We therefore propose to conduct an open label study in patients with active UC to ensure new donors are effective at inducing remission in some patients. Patients that have FMT will relapse within 18 months (PubMed ID: 25857665) although further FMT therapy induces remission so it is possible that maintenance FMT will result in long term remission, but this needs evaluation. We will therefore follow UC patients that have responded to FMT long term in this open label study.
详细描述
This is an open label study with all UC patients receiving FMT. Up to 200 patients with active UC will be recruited to the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 or over
- •Active UC defined as a Mayo score (7) >3
- •A Mayo endoscopic score (7) >0
- •Females of child-bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance
排除标准
- •Participating in another intervention study for UC
- •Unable to give informed consent
- •Severe comorbid medical illness
- •Severe UC requiring hospitalization.
- •Increase in medical therapy for UC in the last 12 weeks. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior to randomization. Relapse on a stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. Stable intake of probiotic therapy also permitted.
- •Antibiotic therapy in the last 30 days.
- •Pregnant women.
- •Patients with clinically significant hepatic dysfunction at the time of screening: ALT > 5 times the upper normal range.
- •Patients with clinically significant renal dysfunction at the time of screening: serum creatinine > 300 µmol/L
- •Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.
结局指标
主要结局
Efficacy of FMT donors at inducing UC remission
时间窗: 9 weeks
Suitability of FMT donors at inducing remission in active UC (remission defined as a Mayo score (7) \< 3 with an endoscopic Mayo score = 0 at the end of 8 weeks of FMT).
Efficacy of FMT at maintaining remission in UC
时间窗: 3 years
Maintenance of remission of UC after three years in those who achieve initial remission with FMT. This is defined as no relapse over three years that requires any medical therapy other than more intense FMT therapy
次要结局
- Efficacy of FMT at relieving PRO2 symptoms(9 weeks)
- Stool microbiota predicting FMT success(9 weeks)
- Efficacy of FMT at in inducing histological remission in active UC(9 weeks)
- Adverse effects of FMT(3 years)
- Efficacy of FMT at improving Quality of life(9 weeks and 3 years)
- Mucosal microbiota predicting FMT success(9 weeks)
研究者
Paul Moayyedi
Principle Investigator
Hamilton Health Sciences Corporation