Tailored Anti-Inflammatory (A-I) Diet for Hispanics with Ulcerative Colitis (UC)

Last updated: March 14, 2025
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Ulcers

Bowel Dysfunction

Treatment

Dietary counseling

Feedback sessions

Catered diet

Clinical Study ID

NCT06784323
20240857
1R01DK140964-01
  • Ages 16-75
  • All Genders

Study Summary

The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the Hispanics/Latino (H/L) diet on disease remission in H/L patients with Ulcerative Colitis (UC) and to identify biomarkers of response to dietary therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented diagnosis with ulcerative colitis from medical records.

  • Self-Identify as Hispanic /Latino

  • 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 Latin foods (starchy vegetables, rice, tropical fruits, plantains)

  • No recent Inflammatory Bowel Disease (IBD) related hospitalization in the lastmonth.

Exclusion

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 oranti-inflammatory diet

  • No active cancer or conditions limiting their ability to follow a diet (heartfailure, 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 studyperiod

  • 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

Total Participants: 122
Treatment Group(s): 4
Primary Treatment: Dietary counseling
Phase:
Study Start date:
March 05, 2025
Estimated Completion Date:
September 01, 2030

Connect with a study center

  • University of Miami Health System

    Miami, Florida 33136
    United States

    Active - Recruiting

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