NCT06784323 · University of Miami
Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)
What this study 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Documented diagnosis with ulcerative colitis from medical records.
- Self-Identify as American
- 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
Where
- Miami, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations