NCT06784323招募中不适用
A Culturally Tailored Anti-inflammatory Diet for American Patients With Ulcerative Colitis
适应症
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
- Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI)
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
结局指标
主要结局
Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI)
时间窗: Up to 8 weeks
Will be measured with SCCAI.
次要结局
- Fecal calprotectin(Up to 8 weeks)
研究者
Oriana Mazorra Damas
Associate Professor
University of Miami
研究点 (2)
Loading locations...
相似试验
进行中（未招募）
不适用
A Culturally Tailored Dietary Intervention to Treat Crohn's DiseaseCrohn DiseaseNCT05627128University of Massachusetts, Worcester150
已完成
不适用
Effect of Anti-inflammatory Diet on Inflammatory, Oxidative and Nutritional Markers in Hemodialysis PatientsInflammationMalnutritionProtein Energy Wasting SyndromeOxidative StressDiet TherapyNCT01874106Maryam Ekramzadeh, PhD120
已完成
不适用
Blueberries, Inflammation, Motivation, and Physical ActivityDepressive SymptomsNCT05735587Hebrew SeniorLife33
招募中
不适用
Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel DiseaseInflammatory Bowel DiseasesNCT06342011The Fourth Affiliated Hospital of Zhejiang University School of Medicine88
进行中（未招募）
不适用
A Culturally-tailored Personalized Nutrition Intervention in South Asian Women at Risk of Gestational DiabetesDiabetes, GestationalNCT03607799McMaster University140