Tailored anti-inflammatory diet for Hispanics with ulcerative colitis
A Culturally Tailored Anti-inflammatory Diet for American Patients With Ulcerative Colitis
This study is testing whether a special anti-inflammatory diet made with traditional Hispanic foods can help Hispanic patients with ulcerative colitis feel better and achieve remission.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 16 Years to 75 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06784323 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of a tailored anti-inflammatory diet that includes traditional Hispanic foods on achieving disease remission in Hispanic/Latino patients with ulcerative colitis. Participants will receive catered meals, dietary guidance, and counseling sessions to support adherence to the diet. The study will also investigate biomarkers that may indicate the effectiveness of the dietary intervention. By focusing on culturally relevant foods, the study seeks to enhance dietary compliance and improve health outcomes.
Who should consider this trial
Good fit: Ideal candidates are Hispanic/Latino individuals aged 16-75 with a documented diagnosis of ulcerative colitis and specific disease activity levels.
Not a fit: Patients with Crohn's disease, recent hospitalizations, or those unable to follow the dietary regimen due to other health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved disease management and remission rates for Hispanic patients with ulcerative colitis.
How similar studies have performed: While dietary interventions for ulcerative colitis have been explored, this specific approach focusing on Hispanic dietary preferences is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Miami, Florida
- University of Miami Health System — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Oriana Damas, MD, MSCTI — University of Miami Health System
- Study coordinator: Oriana Damas, MD, MSCTI
- Email: omazorra@med.miami.edu
- Phone: 305 243-6405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.