Tailored anti-inflammatory diet for Hispanics with ulcerative colitis
Official title: A Culturally Tailored Anti-inflammatory Diet for American Patients With Ulcerative Colitis
Run by University of Miami · NCT06784323 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 16 Years to 75 Years |
| Sex | All |
| Enrollment | 122 (estimated) |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | March 5, 2025 |
| Main results expected | September 1, 2030 |
| Study ends | September 1, 2030 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT06784323 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Hispanic/Latino individuals aged 16-75 with a documented diagnosis of ulcerative colitis and specific disease activity levels.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While dietary interventions for ulcerative colitis have been explored, this specific approach focusing on Hispanic dietary preferences is novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Innovative Multidisciplinary and Virtual Care for IBD in Pregnancy
This study tests a dedicated IBD pregnancy care model, including a new virtual approach, to see if it improves access and quality of care for pregnant people with Crohn's disease or ulcerative colitis.
-
A Probiotic Approach to Modulating Gut Microbiota in Mild-to-Moderate Ulcerative Colitis
A specific probiotic given rectally will be tested in adults with mild-to-moderate ulcerative colitis to see if it can help manage symptoms.
-
Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults
This study tests combinations of risankizumab with either trosunilimab or ABBV-701 in adults with moderately to severely active Crohn's disease or ulcerative colitis.
-
Longitudinal Immunophenotyping of People with Inflammatory Bowel Disease
This study will follow adults with Crohn's disease or ulcerative colitis (and some healthy relatives) over three years to see how their immune cells change over time and how genetics and diet relate to their disease.
-
High Protein, High Fiber Diet for Ulcerative Colitis
This study tests a high-protein, high-fiber diet to see if it helps people with ulcerative colitis by meeting protein needs and lowering harmful hydrogen sulfide production in the gut.
-
Ath-063: Testing a new treatment for moderately to severely active ulcerative colitis in patients who have tried other biologics
This study tests ATH-063 to see if it helps people with moderate to severe ulcerative colitis who did not respond to or relapsed after prior biologic therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.