Targeting Gut Inflammation Through Diet: a Tailored American Diet for Patients With Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response
研究概览
简要总结
The purpose of this study is to test the effect of an anti-inflammatory diet tailored for patients living in the United States with Crohn's Disease (CD) on clinical symptoms and disease inflammation and to identify biomarkers of response to dietary therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis with Crohn's Disease from medical records.
- •Ages 16-75
- •Mild to moderately active CD disease, defined by one of the following criteria:
- •Crohn's disease activity index (CDAI) 150-250 (mild-to-moderate only active disease) AND presence of active inflammation either by: fecal calprotectin >150mg/dl. or radiologic findings of active ileal and/or colonic disease, or endoscopic findings showing active ileal and/or colonic disease within 4 weeks of baseline
- •On stable medications for their disease as or 3 months if medication is not listed
排除标准
- •Diagnosis of Ulcerative Colitis (UC).
- •Prior J pouch or diversion
- •Recent inflammatory bowel disease (IBD) related hospitalizations in the last 4 weeks
- •Clostridium difficile or enteric infections in the last 4 weeks
- •Use of probiotics in the last 4 weeks
- •Patients following the specific carbohydrate diet or Mediterranean diet or anti-inflammatory diet
- •Active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)
- •Pregnancy, breastfeeding or planning to become pregnant during study period
- •Use of Total Parenteral Nutrition at the time of screening and during the study period
- •Other significant or life-threatening co-morbidities
- •The need for antibiotic use during the study period
- •Adults unable to consent
- •Ages < 16 and > 75 years old
- •Prisoners
- •Crohn's specific complicated disease including active Stenotic (stricturing, B2) disease within the past 12 months, or Internal penetrating (B3) disease, or Draining perianal fistula, or Prior bowel resection
- •Patients with concomitant Celiac disease
研究组 & 干预措施
Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance Group
Participants in this group will first receive an 8-week catered anti-inflammatory diet intervention, followed by a 2-week washout period, then an 8-week diet guidance period in which they consume their usual diet with weekly counseling focused on safe food preparation.
干预措施: Diet Guidance for Usual Diet (Behavioral)
Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet Group
Participants in this group will first receive an 8-week diet guidance period with weekly counseling while consuming their usual diet, followed by a 2-week washout period, then an 8-week catered anti-inflammatory diet intervention.
干预措施: Catered Anti-Inflammatory Diet (Behavioral)
Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet Group
Participants in this group will first receive an 8-week diet guidance period with weekly counseling while consuming their usual diet, followed by a 2-week washout period, then an 8-week catered anti-inflammatory diet intervention.
干预措施: Diet Guidance for Usual Diet (Behavioral)
Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance Group
Participants in this group will first receive an 8-week catered anti-inflammatory diet intervention, followed by a 2-week washout period, then an 8-week diet guidance period in which they consume their usual diet with weekly counseling focused on safe food preparation.
干预措施: Catered Anti-Inflammatory Diet (Behavioral)
结局指标
主要结局
Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response
时间窗: Baseline, Week 8, Week 10, Week 18
Clinical response is defined as a ≥70-point reduction from baseline in the Crohn's Disease Activity Index (CDAI). The outcome is the percentage of participants who achieve this response following the dietary intervention.
Participants Achieving Fecal Calprotectin (FC) Reduction
时间窗: Baseline, Week 8, Week 10, Week 18
Reduction is defined as a \>50% decrease from baseline in fecal calprotectin (FC). The outcome is the percentage of participants who achieve this reduction.
次要结局
- Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission(Baseline, Week 8, Week 10, Week 18)
研究者
Oriana Mazorra Damas
Associate Professor of Medicine
University of Miami