Actively Recruiting

Phase Not Applicable
Age: 16Years - 75Years
All Genders
NCT06784323

Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)

Led by University of Miami · Updated on 2026-03-30

122

Participants Needed

1

Research Sites

286 weeks

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)

Who Can Participate

Age: 16Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented diagnosis of ulcerative colitis from medical records
  • Self-identify as American
  • Aged between 16 and 75 years
  • Simple Clinical Colitis Activity Index (SCCAI) score between 3 and 9
  • Fecal calprotectin greater than 150 mg/dl
  • Stable medications for ulcerative colitis for at least 3 months
  • Likeability of American foods such as sandwiches, BBQ or grilled meats and vegetables, baked potatoes, smoothies, salmon, oatmeal, avocado, and soups
  • No inflammatory bowel disease related hospitalization in the last month
Not Eligible

You will not qualify if you...

  • Diagnosis of Crohn's Disease
  • Prior ileoanal anastomosis (J-pouch) or diversion surgery
  • Hospitalizations in the last 4 weeks
  • Clostridium difficile or other enteric infections in the last 4 weeks
  • Use of probiotics in the last 4 weeks
  • Following specific carbohydrate, Mediterranean, or anti-inflammatory diets
  • Active cancer or medical conditions limiting diet adherence such as heart failure or end-stage renal disease
  • Pregnancy, breastfeeding, or planning pregnancy during the study
  • Use of Total Parenteral Nutrition at screening or during study
  • Significant or life-threatening co-morbidities
  • Need for antibiotic use during the study
  • Adults unable to provide consent
  • Age less than 16 or greater than 75 years
  • Prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Miami Health System

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

O

Oriana Damas, MD, MSCTI

CONTACT

E

Eytan I Stern, MS, RD, LD/N, CNSC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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