Impact of Anti-Inflammatory Whole-Food Diet in Crohn's Disease and Predicting Response to Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease
研究概览
简要总结
Patients with inflammatory bowel disease (IBD) often have narrowed microbial diversity and altered composition and function of the gut microbiome. We anticipate the anti-inflammatory diet, when compared with the usual diet, to produce favorable changes in these multi-omics profiles. These findings will provide insight into the interactions between diet and host biology, while providing clues on the mechanisms of diet therapy's effect and CD pathogenesis.
详细描述
A randomized controlled trial of the anti-inflammatory whole food diet versus usual diet for the induction of remission in 104 adults with mild-to-moderate Crohn's Disease (CD). The anti-inflammatory whole food diet will be compared to participants usual diet for understanding its effects on achieving clinical remission, clinical response, reduction in serological and fecal markers of inflammation, and improvement in patient-reported outcomes, such as physical activity, anxiety, depression, fatigue, pain, sleep disturbance, social satisfaction, and quality of life. The study will involve collection of blood and fecal specimens to evaluate the effects of the anti-inflammatory diet on the gut microbiome, bacterial metabolome, innate immune markers, and fecal microRNA profiles. The participants will be placed on anti-inflammatory diet for 8 weeks and assessed every 2 weeks for adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 to 75 years old
- •History of Crohn's Disease (CD) with mild to moderate symptoms and prior biopsy proof
排除标准
- •History or current diagnosis of any of the following:
- •Stroke or Arrhythmia
- •Liver Disease
- •Untreated hypertension (High Blood Pressure)
- •Active malignancy
- •Bleeding disorders
- •Heart Disease
- •Lung disease
- •Previous Heart surgery
- •Previous Gastrointestinal Surgery
- •Kidney Disease
- •Chronic Diarrhea
- •End enterostomy
- •Laxative Abuse
- •Endocrine Disorder
- •Current history of smoking tobacco
- •Urgent need for abdominal sugery
- •Severe Malnutrition
- •Active alcohol or non-cannabinoid substance abuse
- •Recent hospitalization within the last 30 days
- •Currently pregnant of lactating.
- •Current use probiotics or dietary supplements that would not be willing to discontinue for the length of the study.
- •Concerns for non-compliance
- •If currently on immunosuppressants, immunomodulators, cotticosteroids, and/or 5-aminosalicylates, no changes in doses will be permitted during the trial except for tapering of corticosteroids.
结局指标
主要结局
Efficacy of the anti-inflammatory whole food diet for the induction of remission in Crohn's Disease
时间窗: 8 weeks
The patients' clinical response, defined by the Harvey-Bradshaw Index (HBI) (5 through 16 points) for clinical symptom improvement and/or remission.
次要结局
未报告次要终点
研究者
Zhaoping Li
Principal Investigator
University of California, Los Angeles