Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 3
- 主要终点
- Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores
研究概览
简要总结
The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial
详细描述
This study involves the assessment of the safety and efficacy of FMT in the treatment and induction of remission for patients with mild to moderate ulcerative colitis. It is a double blind study with patients randomised in a 1:1 manner to either active or placebo therapy
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ulcerative colitis >3 months duration
- •Active mild-moderate ulcerative colitis (Mayo 4-10)
- •Ulcerative colitis of any extent except isolated proctitis < 5cm
- •Live within driving distance of clinical site (to attend multiple study visits)
排除标准
- •Pregnancy
- •Active gastrointestinal infection
- •Other gastrointestinal disease / comorbidities
- •Prior colonic surgery
- •Recent antibiotic or probiotic use
- •Prednisone > 20mg
- •Monoclonal antibody immunosuppressive therapy
研究组 & 干预措施
FMT infusions
FMT infusions constituted from stool provided by healthy, screened donors
干预措施: FMT infusions (Biological)
Placebo arm
Placebo infusions
干预措施: Placebo infusion (Other)
结局指标
主要结局
Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores
时间窗: 8 weeks
次要结局
- Clinical remission as measured by Mayo subscores(8 weeks)
- Endoscopic healing as measured by UCEIS(8 weeks)
- Treatment failure rate as defined by Mayo subscores(8 weeks)
- Safety and tolerability as measured by adverse event data(8 weeks)
- Clinical response as measured by Mayo subscores(8 weeks)
- Quality of life as measured by IBDQ(8 weeks)
研究者
Dr. Sudarshan Paramsothy
Gastroenterologist / PhD candidate
The University of New South Wales