Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)
Recruiting · NCT06784323 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Miami
View the official record on ClinicalTrials.gov →Interventions studied
Catered dietDiet guidance sessionsDietary counselingFeedback sessions
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.
Who can take part
Age range
16 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- University of Miami Health System - Miami, Florida, United States