Clinical trial Recruiting at 1 site Interventional Ages 16 to 75

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 typeInterventional
Ages16 Years to 75 Years
SexAll
Enrollment122 (estimated)
SponsorUniversity of Miami
Academic / other
Locations1 site (Miami, Florida)
StatusRecruiting
StartedMarch 5, 2025
Main results expectedSeptember 1, 2030
Study endsSeptember 1, 2030
Registry record updatedMarch 30, 2026
Trial IDNCT06784323 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.