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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a diet meant to lower inflammation, using familiar American foods, can help keep ulcerative colitis (UC) under control. UC causes swelling and sores in the large intestine. The study is for Americans with UC and also looks for signs in the body that show a response to the diet.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have UC confirmed in your medical records.
  • Identify as American and be 16–75 years old.
  • Have a UC symptom score called SCCAI of 3–9, with no more than 12 bowel movements a day.
  • Have a stool calprotectin level above 150 mg/dl. This test measures inflammation in the gut.
  • Have been on stable medicines for UC for the past 3 months.
  • Like American foods, such as sandwiches, grilled meats and vegetables, baked potatoes, smoothies, salmon, oatmeal, avocado, and soups.
  • Have had no hospital stays related to inflammatory bowel disease in the past month.

Who can't join

  • Have Crohn’s disease, or have had surgery to create a J-pouch or reroute stool.
  • Must have had no hospital stays, gut infections such as C. difficile, or probiotic use in the past 4 weeks.
  • Already follow a specific carbohydrate, Mediterranean, or anti-inflammatory diet.
  • Have active cancer, heart failure, kidney failure, or another serious condition that limits following the diet or threatens your life.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Get all nutrition through a vein at screening or during the study, or need antibiotics during the study.
  • Are an adult unable to give consent, or are younger than 16 or older than 75.
  • Are a prisoner.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

FL