RECRUITING

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

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Conditions

Ulcerative Colitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Culturally Tailored Anti-inflammatory Diet for American Patients With Ulcerative Colitis

Quick Facts

Study Start:2025-03-05
Study Completion:2030-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06784323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented diagnosis with ulcerative colitis from medical records.
  2. * Self-Identify as American
  3. * Ages 16-75
  4. * SCCAI between 3-9 (no greater than 12 bowel movements a day)
  5. * Fecal calprotectin \> 150mg/dl.
  6. * On stable medications for their disease for the past 3 months
  7. * Likeability of American foods (sandwiches, BBQ or grilled meats and vegetables, baked potatoes, smoothies, salmon, oatmeal, avocado, soups)
  8. * No recent Inflammatory Bowel Disease (IBD) related hospitalization in the last month.
  1. * Diagnosis of Crohn's Disease (CD).
  2. * Prior ileoanal anastomosis (J-pouch) or diversion
  3. * No recent hospitalizations on the last 4 weeks
  4. * No Clostridium difficile or enteric infections on the last 4 weeks
  5. * No use of probiotics on the last 4 weeks
  6. * Patients following the specific carbohydrate diet or mediterranean diet or anti-inflammatory diet
  7. * No active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)
  8. * Pregnancy, breastfeeding or planning to become pregnant during study period
  9. * Use of Total Parenteral Nutrition at the time of screening and during the study period
  10. * Other significant or life-threatening co-morbidities
  11. * The need for antibiotic use during the study period
  12. * Adults unable to consent
  13. * Ages less than 16 and \> 75 years old
  14. * Prisoners

Contacts and Locations

Study Contact

Oriana Damas, MD, MSCTI
CONTACT
305 243-6405
omazorra@med.miami.edu
Eytan I Stern, MS, RD, LD/N, CNSC
CONTACT
305 243-6405
eis43@miami.edu

Principal Investigator

Oriana Damas, MD, MSCTI
PRINCIPAL_INVESTIGATOR
University of Miami Health System

Study Locations (Sites)

University of Miami Health System
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Oriana Damas, MD, MSCTI, PRINCIPAL_INVESTIGATOR, University of Miami Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-05
Study Completion Date2030-09-01

Study Record Updates

Study Start Date2025-03-05
Study Completion Date2030-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Ulcerative Colitis