Anti-Inflammatory Diet (Dieta Antiinflamatoria or DAIN in Spanish): a Crohn's Disease Management Strategy Tailored for Puerto Ricans
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Improvement of health-related quality of life
研究概览
简要总结
The goal of the study is to test the efficacy of a dietary intervention in inducing clinical response and remission for patients with Crohn's disease in a randomized controlled trial. The intervention diet: DAIN has been adapted from the Inflammatory Bowel Disease Anti-Inflammatory Diet or IBD-AID™ taking into account the food availability and preferences of Puerto Ricans. DAIN also includes traditional foods commonly consumed in the typical Puerto Rican diet while maintaining the fundamental components of the IBD-AID™.
详细描述
Crohn's disease is a chronic recurrent inflammatory disorder of the gastrointestinal that results from an inappropriate inflammatory response to an altered gut microbiome (i.e., dysbiosis). Diet is the main driver of microbiome composition. Diet also has been increasingly recognized as a cost-effective strategy to induce remission in pediatric and adult patients with Crohn's disease but diets that can substitute traditional and locally available foods among Puerto Ricans have not been explored. DAIN, a newly created dietary program, incorporates an extensive patient curriculum of recipes and menus adapted to the local availability and food preferences of Puerto Rican patients with Crohn's disease. This study aims to address three questions: whether DAIN a diet adapted to Puerto Rican patients with Crohn's disease, can: 1) induce clinical response and remission; 2) change the inflammatory tone, and 3) revert dysbiosis in Crohn's disease patients.
Participants will be randomized 1:1 ratio into two arms:
- Arm 1 Crohn's disease patients + DAIN (Experimental): this group of patients will participate in ten weeks of DAIN intervention (From week 1 to week 10)
- Arm 2 Crohn's disease patients no intervention (Control): this group of patients will not participate in the DAIN dietary intervention and will continue the usual diet.
Participation in the study lasts for 15 weeks with four-time points: week 0 (baseline), week 6, week 10, and week 14. At each time point, all subjects will complete a series of questionnaires to assess overall health, Crohn's disease activity, and dietary compliance. Blood and stool samples will be also collected at home at each time point. Samples will be either shipped or brought to the Research Unit at the Inflammatory Bowel Disease Clinic at the University of Puerto Rico.
The primary outcome is Improvement of health-related quality of life. Secondary outcomes are: (i) reduction of inflammation, (ii) changes in the gut microbiome, (iii) clinical response and remission,and (iii) dietary compliance.
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 (Investigator, Outcomes Assessor)
盲法说明
All staff collecting data (e.g., dietary assessment) or assaying samples (e.g., fecal calprotectin, cytokines, sequencing) including the PI's, will be blinded to diet group assignments.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21 to 65 years old
- •Confirmed CD diagnosis with sCDAI <450 (includes values ranging from remission, mild to moderate activity)
- •Moderate to severe impaired QoL (sIBDQ<60)
- •Stable doses of medications are screened; thiopurines, natalizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab, vedolizumab (8 weeks), 5-aminosalicylic acid (5-ASA) (2 weeks), steroids (1 week)
- •Willingness and capacity to significantly change diet (arm 1)
- •Willing and able to comply with specimen collection and other study procedures, and to complete the study
排除标准
- •Use of Specific Carbohydrate Diet of IBD-AID™ within 4 weeks of screening
- •Use of prescribed probiotics within 4 weeks of screening
- •> 20mg prednisone or equivalent
- •Recent C. difficile colitis
- •Pregnancy
- •Presence of symptomatic or significant structure or history of obstruction in the past 6 months
研究组 & 干预措施
Arm 2: Crohn's disease patients no intervention
Participants will continue consuming their usual diet, with no intervention
Arm1: Crohn's disease patients + DAIN
Participants will have 10 weeks of DAIN intervention (From week 1 to week 10)
干预措施: DAIN (Other)
结局指标
主要结局
Improvement of health-related quality of life
时间窗: Week 0, 6, 10, 14
Improvement of health-related quality of life (increase of the short Inflammatory Bowel Disease Questionnaire score (SIBDQ)). The SIBDQ scores range between 10 and 70 points. A slightly impaired quality of life is indicated by scores from 60 to 70 points, moderately impaired quality of life from 45 to 60 points, and severely impaired quality of life from 10 to 45 points.
次要结局
- Change of Inflammation(Week 0, 6, 10, 14)
- Gut Microbiome changes(Week 0, 6, 10, 14)
- Dietary compliance(Week 0, 6, 10, 14)
- Clinical response and remission(Week 0, 6, 10, 14)
研究者
Ana Maldonado-Contreras
Assitant Professor
University of Massachusetts, Worcester