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New treatment option for Ulcerative Colitis
Official title Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)
ClinicalTrials.gov ID: NCT06784323
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 75
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.