Implementing Metabolomics Informed Diet on Inflammatory Bowel Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- short Crohn's Disease Activity Index (sCDAI)
研究概览
简要总结
The effects of diet on inflammatory bowel disease is an under-studied area of research. The investigators are interested in further investigating the role that diet contributes to inflammatory bowel disease severity. The investigators will collect blood and stool samples from patients with inflammatory bowel disease (IBD) before and after diet changes. The stool samples will be analyzed using metabolomics and microbiome analysis to determine changes after the new diet has been implemented. The investigators will then compare changes in the patient's overall disease state by measuring markers of inflammation including C-reactive protein (CRP) and fecal calprotectin to determine how this diet affects the disease state.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •18 years old or older
- •Meet classification criteria for inflammatory bowel disease including those with mild to moderate Crohn's Disease as defined by a Crohn's disease activity index between 150-450, with fecal calprotectin>250, within 1 month of enrollment.
排除标准
- •Unable to provide informed consent
- •History of or current drug abuse
- •Pregnancy
- •Start or change in dose of standard-of-care treatment within 12 weeks of the screening
- •Known allergy to any component of the proposed diet
- •Subjects with significant other medical or psychiatric comorbidities and /or medication use which in
- •physician's clinical judgment might difficult the interpretation of the results
- •Patients that are not on a stable dose of medications, for instance, steroids, in between samples collection
- •Patients on antibiotics
- •Patients with C difficile infection within 4 weeks of enrollment
结局指标
主要结局
short Crohn's Disease Activity Index (sCDAI)
时间窗: 42 Days
Mild to moderate Crohn's Disease is defined by a short Crohn's Disease activity index (sCDAI) between 150-450, while those in remission from Crohn's Disease have an sCDAI score below 150. An sCDAI score exceeding 450 is used as a marker of severe Crohn's Disease.
次要结局
未报告次要终点
研究者
Monica Guma
Associate Professor
University of California, San Diego