Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal (MIRACLE)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 15
- 主要终点
- Clinical remission (defined by a CDAI <150) at week 52 (V8) without any flare between week 0 (colonoscopy (V2)) and week 52 (V8). Flare is defined by a CDAI (Addendum 2) above 250 or between 150 points and 250 points with a 70-point increase from baseline (v0 : inclusion) over 2 consecutive weeks and the need to start any new treatment for CD.
研究概览
简要总结
Evaluate the clinical efficacy at week 52 (V8) of FMT versus sham transplantation as a maintenance treatment following anti-TNF agent withdrawal in patients with Crohn’s disease in steroid-free clinical remission for at least 6 months under anti-TNF agent.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years and < 75 years
- •Crohn’s disease (according to the Lennard-Jones criteria) for at least 6 months
- •Patient in steroid-free clinical remission for at least 6 months under anti-TNF agent (no clinical evidence of flare nor change in Crohn’s disease specific treatment (anti-TNF, immunosuppressive, …) within 6 months before inclusion) and CDAI <150 the week before inclusion) and willing to withdraw anti-TNF treatment
- •Female of child-bearing age with an active contraception and this during at least the period of treatment
- •Patient with health insurance
- •Informed Written consent
- •Healthy volunteers donors :Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day
排除标准
- •Crohn’s Disease complication requiring surgical treatment
- •Contraindication to colonoscopy or anesthesia
- •Pregnancy or breastfeeding during the study
- •Diagnosis of Crohn’s disease restricted to the upper gastrointestinal tract (oesophagus, stomac, duodenum, jejunum)
- •Patient with active perineal disease (defined as evidence of perineal abscess or active draining fistula or presence of seton or presence of perineal ulceration)
- •History of more than one small bowel resection or small intestine resection > 1 meter
- •Current stoma (Ileostomy or a colostomy) or stoma in the last 6 months or any other intra-abdominal surgery within 3 months prior to inclusion.
结局指标
主要结局
Clinical remission (defined by a CDAI <150) at week 52 (V8) without any flare between week 0 (colonoscopy (V2)) and week 52 (V8). Flare is defined by a CDAI (Addendum 2) above 250 or between 150 points and 250 points with a 70-point increase from baseline (v0 : inclusion) over 2 consecutive weeks and the need to start any new treatment for CD.
Clinical remission (defined by a CDAI <150) at week 52 (V8) without any flare between week 0 (colonoscopy (V2)) and week 52 (V8). Flare is defined by a CDAI (Addendum 2) above 250 or between 150 points and 250 points with a 70-point increase from baseline (v0 : inclusion) over 2 consecutive weeks and the need to start any new treatment for CD.
次要结局
- Relapse free survival rate from week 0 (V2) to week 52 (V8)
- Proportion of endoscopic remission (SES-CD ≤2) at week 52 (V8) and change (in %) in endoscopic score (SES-CD) between week 0 (V2) and 52 (V8)
- Clinical remission defined by a CDAI < 150 at week 52; endoscopic remission defined by a SES-CD ≤ 2.
- Measures of inflammation: blood cell count, CRP level, fecal calprotectin at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8)
- Microbiota composition and diversity using 16s sequencing technology at week 6 (V3), 12 (V4), 24 (V5), 36 (V6), 48 (V7) and 52 (V8)
研究者
Pr Harry SOKOL
Scientific
Assistance Publique Hopitaux De Paris