Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Rutgeerts endoscopic score
研究概览
简要总结
Curcumin, the active ingredient of turmeric, has been used for long term in the treatment of inflammatory conditions. Inhibition of NF-κB is postulated as the main mechanism responsible for the anti-inflammatory effect of curcumin
Aim : to study the effect of curcumin, 3g per day, as compared to placebo, combined with thiopurines in the prevention of Crohn's disease post-operative recurrence.
详细描述
122 subjects, operated on for Crohn disease, will be included in the study. After ileo-colonic resection, subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria.
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
- Double (Participant, 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
- •Crohn's disease confirmed by radiographic, endoscopic or histologic criteria
- •Age > 18 yr
- •Affiliated to french health insurance
- •Operated on less than 15 days ago for ileal, colonic or ileo-colonic Crohn's disease with all macroscopic lesions being removed, with an anastomosis which can be reached by ileocolonoscopy
排除标准
- •Ulcerative colitis
- •Pregnant or nursing woman
- •Refusal of contraceptive measure for childbearing potential, woman or fertile man
- •Indication of anti-TNFα treatment
- •Concomitant treatment including antibiotics, probiotics, mesalazine, methotrexate, cyclosporine, tacrolimus, anti-TNFα, ustekinumab, vedolizumab
- •Concomitant treatment with corticosteroids, except in case of tapering a treatment initiated before surgery
- •Renal insufficiency ( serum creatinine 2N)
- •Chronic hepatic disease except for primary sclerosing cholangitis
- •ALAT , ASAT, alkaline phosphatases, or bilirubin > 3N
- •Current infection to HIV, HBV (except if HBV Ac positives), HCV
- •Contraindication to thiopurines
- •Unwillingness of the patient
研究组 & 干预措施
CURCUMIN
subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria
干预措施: Curcumin (Drug)
PLACEBO
subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria
干预措施: Curcumin (Drug)
结局指标
主要结局
Rutgeerts endoscopic score
时间窗: at 6 months
次要结局
- Rutgeerts endoscopic score according to length of intestinal resection >0.5m(at 6 months)
- Rutgeerts endoscopic score according to a fistulising phenotype (yes/no)(at 6 months)
- CDAI score(at 6 months and at 1 year)
- Rutgeerts endoscopic score according to smoking status (yes/no)(at 6 months)
- Rutgeerts endoscopic score according to anoperineal lesions (yes/no)(at 6 months)
- Rutgeerts endoscopic score according to previous intestinal surgery (yes/no)(at 6 months)