A Culturally Tailored Anti-inflammatory Diet for American Patients With Ulcerative Colitis

University of Miami2 个研究点分布在 1 个国家目标入组 122 人开始时间: 2025年3月5日最近更新: 2026年3月30日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: University of Miami
入组人数: 122
试验地点: 2
主要终点: Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the American diet on disease remission in American patients with Ulcerative Colitis (UC) 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: Supportive Care
盲法: Single (Participant)

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 ulcerative colitis from medical records.
•Self-Identify as American
•Ages 16-75
•SCCAI between 3-9 (no greater than 12 bowel movements a day)
•Fecal calprotectin > 150mg/dl.
•On stable medications for their disease for the past 3 months
•Likeability of American foods (sandwiches, BBQ or grilled meats and vegetables, baked potatoes, smoothies, salmon, oatmeal, avocado, soups)
•No recent Inflammatory Bowel Disease (IBD) related hospitalization in the last month.

排除标准

•Diagnosis of Crohn's Disease (CD).
•Prior ileoanal anastomosis (J-pouch) or diversion
•No recent hospitalizations on the last 4 weeks
•No Clostridium difficile or enteric infections on the last 4 weeks
•No use of probiotics on the last 4 weeks
•Patients following the specific carbohydrate diet or mediterranean diet or anti-inflammatory diet
•No 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 less than 16 and > 75 years old
•Prisoners