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Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)
NCT06784323 · University of Miami
In plain English
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Official title
A Culturally Tailored Anti-inflammatory Diet for American Patients With Ulcerative Colitis
About this study
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.
Eligibility 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
Study design
Enrollment target: 122 participants
Allocation: randomized
Masking: single
Age groups: child, adult, older_adult
Timeline
Starts: 2025-03-05
Estimated completion: 2030-09-01
Last updated: 2026-03-30
Interventions
Behavioral: Catered dietBehavioral: Diet guidance sessionsBehavioral: Dietary counselingBehavioral: Feedback sessions
Primary outcomes
- • Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI) (Up to 8 weeks)
Sponsor
University of Miami · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactOriana Damas, MD, MSCTI · contact · omazorra@med.miami.edu · 305 243-6405
ContactEytan I Stern, MS, RD, LD/N, CNSC · contact · eis43@miami.edu · 305 243-6405
InvestigatorOriana Damas, MD, MSCTI · principal_investigator, University of Miami Health System
All locations (1)
University of Miami Health SystemRecruiting
Miami, Florida, United States