Tailored Anti-Inflammatory American Diet for Patients With Crohn's Disease

Starting soon · Not applicable

Conditions studied: Crohn's Disease, Active, Crohn's Disease (CD), Diet Interventions

In brief

The purpose of this study is to test the effect of an anti-inflammatory diet tailored for patients living in the United States with Crohn's Disease (CD) on clinical symptoms and disease inflammation and to identify biomarkers of response to dietary therapy.

Key facts

Study ID

NCT07671872

Run by

University of Miami

People needed

122

Starts

2026-08-01

Expected to finish

2030-08-01

Last updated by the study team

2026-06-26

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis with Crohn's Disease from medical records.
• Ages 16-75
• Mild to moderately active CD disease, defined by one of the following criteria:
• Crohn's disease activity index (CDAI) 150-250 (mild-to-moderate only active disease) AND presence of active inflammation either by: fecal calprotectin >150mg/dl. or radiologic findings of active ileal and/or colonic disease, or endoscopic findings showing active ileal and/or colonic disease within 4 weeks of baseline
• On stable medications for their disease as or 3 months if medication is not listed

You may not qualify if…

• Diagnosis of Ulcerative Colitis (UC).
• Prior J pouch or diversion
• Recent inflammatory bowel disease (IBD) related hospitalizations in the last 4 weeks
• Clostridium difficile or enteric infections in the last 4 weeks
• Use of probiotics in the last 4 weeks
• Patients following the specific carbohydrate diet or Mediterranean diet or anti-inflammatory diet
• 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 < 16 and > 75 years old
• Prisoners
• Crohn's specific complicated disease including active Stenotic (stricturing, B2) disease within the past 12 months, or Internal penetrating (B3) disease, or Draining perianal fistula, or Prior bowel resection
• Patients with concomitant Celiac disease

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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