Food and Crohn's Exacerbation Study (FACES)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Relapse of Crohn's Disease (CD)
研究概览
简要总结
The proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding month. Disease activity will be assessed with the abbreviated Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be assessed during follow-up using an internet-based questionnaire. Repeat assessment of adherence to the study diets will be assessed with food frequency questionnaires (FFQs) administered after 20 weeks. Follow-up duration will be for 48 weeks. Statistical analysis will compare the time to relapse using Cox regression for patients in the two study arms. In the exploratory aim, we will compare outcomes among patients in the highest tertile for other food items and nutrients to those in the lowest tertile based on self-reported usual dietary patterns at baseline. Thus, the study population will be analyzed both as a randomized controlled trial and as a prospective cohort study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have an established diagnosis of CD.
- •All patients must be in clinical remission at the time of entry into the study. Remission is defined as an aCDAI of less than 150.
排除标准
- •Inflammatory bowel disease (IBD) unspecified / Indeterminate colitis
- •Total or sub-total colectomy, ileostomy, or colostomy
- •Unable to read and speak English
- •No internet access
- •Steroids other than budesonide ≤6mg/day with the prior two weeks
- •Perianal fistula or abscess with more than scant drainage
- •Age less than 18 years
- •Pregnant or breastfeeding women
- •Unwilling to follow the study diet
结局指标
主要结局
Relapse of Crohn's Disease (CD)
时间窗: Every 8 weeks during the 48 week study period
Relapse of CD is defined as an increase in the aCDAI by \>=60 points and to \>150. Additionally, undergoing CD surgery or starting any new CD medication (steroids, mesalamine, azathioprine, methotrexate, anti-Tumor Necrosis Factor α (anti-TNF), anti-α4) for the treatment of CD symptoms during the interval between two visits will be considered to have identified a clinical relapse.
次要结局
未报告次要终点