NCT04946448招募中不适用
COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Steroid-free clinical and biochemical remission
研究概览
简要总结
This study is a randomised open label study, comparing the FIT diet with standard diet in patients with Crohn's disease treated with biologic 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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-80 years)
- •active inflammation of terminal ileum and/or colon with a Simple Endoscopic Score for Crohn's Disease (SES-CD) greater than 5 (or greater than 3 for patients with isolated ileitis),
- •patient reported outcome 2 (PRO2 - 7 day average daily stool frequency x 2 + 7 day average daily abdominal pain score x 5) > 8,
- •faecal calprotectin above 250 µg/g.
排除标准
- •Bowel resection within 6 months before enrolment,
- •Short-bowel syndrome,
- •Clinically significant stricture that could require surgery,
- •Pregnant,
- •Lactating woman or desire to become pregnant during the study,
- •Unwilling or unable to follow the study diet.
结局指标
主要结局
Steroid-free clinical and biochemical remission
时间窗: Month 6
Normalization of faecal calprotectin (\< 250 µg/g) and steroid-free clinical remission, defined as patient PRO2 ≤ 8 (average daily stool frequency ≤ 1.5 AND average daily abdominal pain score ≤ 1), at month 6.
次要结局
- Health-related quality of life(6 months and 1 year)
- Endoscopic improvement(1 year)
- Clinical remission(6 months and 1 year)
- Steroid-free clinical remission(6 months and 1 year)
- Endoscopic remission(1 year)
- Fatigue(6 months and 1 year)
- CRP improvement(6 months and 1 year)
- Clinical response(6 months and 1 year)
- Number of participants without nutritional deficiencies(6 months and 1 year)
- Fecal calprotectin improvement(6 months and 1 year)
研究者
研究点 (1)
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