A Multi-centre, Randomised Controlled Trial Comparing Fecal Microbiota Transplantation to Placebo in an Expanded Ulcerative Colitis Population: a Feasibility Study (FRONTIER-UC)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Steroid-free endoscopic remission
研究概览
简要总结
This is a multi-centre, randomised controlled trial comparing fecal microbiota transplantation to placebo in an expanded ulcerative colitis population: a feasibility study (FRONTIER-UC) to determine whether a full-scale randomized controlled trial (RCT) to investigate fecal microbiota transplantation (FMT) in ulcerative colitis (UC) is feasible.
详细描述
This is a randomized, double blind, placebo-controlled trial for UC patients with active disease.
Participants will be grouped into one of two categories
- Add to current therapy (i.e., adjunct therapy)
or 2. Initiate or switch to a new advanced agent (i.e., co-administration)
The study will recruit 85 outpatients at 3 Canadian healthcare centres
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
- •18 years of age or older
- •Able to provide informed consent
- •Established UC diagnosis through standard endoscopic and histologic criteria
- •Use of effective contraception method for women of childbearing potential for at least 4 weeks prior to receiving study treatment and for the duration of the trial
- •Willing and able to comply with all required study procedures
排除标准
- •Severe UC requiring hospitalization
- •Crohn's disease or indeterminate colitis
- •Irritable bowel syndrome
- •Intestinal infection within 4 weeks of enrollment
- •Evidence of toxic megacolon or gastrointestinal perforation on imaging
- •Planned colectomy
- •Abdominal surgery within 60 days of enrollment
- •Neutropenia with absolute neutrophil count <0.5 x 109/L
- •Peripheral white blood cell count > 35.0 x 109/L and fever (>38C)
- •Planned or actively taking another investigational product
- •Uncontrolled medical conditions such as psychiatric disorders or substance abuse
- •Severe underlying disease such that the patient is not expected to survive for at least 30 days
- •Pregnancy or breastfeeding
- •Unwilling to discontinue non-dietary probiotic
- •Antibiotic use 30 days prior to enrollment or anticipated need for systemic antibiotic use during study
- •FMT for any reason within 6 months of enrollment
- •Investigator's judgement that enrolment is not in the best interest of the patient
研究组 & 干预措施
Co-Administration therapy group (Plcebo)
The placebo capsules will appear identical to LFMT capsules and same dosing will apply.
干预措施: Placebo (Other)
Adjunct therapy group (LFMT)
Induction phase: 4 capsules a day x 1 week, 2 capsules a day x 1 week, followed by 1 capsule daily x 6 weeks
Maintenance phase: 1 capsule daily x 16 weeks
干预措施: Lyophilized Fecal Microbiota Transplantation (LFMT) (Other)
Adjunct therapy group (Placebo)
The placebo capsules will appear identical to LFMT capsules and same dosing will apply.
干预措施: Placebo (Other)
Co-Administration therapy group (LFMT)
Induction phase: 4 capsules a day x 1 week, 2 capsules a day x 1 week, followed by 1 capsule daily x 6 weeks
Maintenance phase: 1 capsule daily x 16 weeks
干预措施: Lyophilized Fecal Microbiota Transplantation (LFMT) (Other)
结局指标
主要结局
Steroid-free endoscopic remission
时间窗: At 8 weeks
Steroid-free endoscopic remission is defined as either 1. Mayo endoscopy score (MES)= 0 OR 2. MES=1 + FC \<150 µg/g
次要结局
- Serious adverse events [SAE](up to week 24 or at time of withdrawal)
- Adverse outcomes(up to week 24 or upon withdrawal)
- Quality of Life- sIBDQ(Baseline to 8 weeks and 24 weeks)
- Quality of Life- WPAI-IBD(Baseline to 8 weeks and weeks 24)