Tailored Anti-Inflammatory Diet for Crohn's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will assess a diet tailored to reduce inflammation in adults aged 16-75 with mild-to-moderate Crohn’s disease in the United States. Participants will follow a catered anti-inflammatory diet or receive guidance for following their usual diet, with ongoing monitoring of clinical symptoms and inflammatory markers. Researchers will explore biomarkers that may indicate how well individuals respond to dietary therapy. The study is led by the University of Miami with collaboration from the U.S. Department of Defense and is based in Miami, FL.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Oriana M Damas, MD, MSCTI — University of Miami
• Study coordinator: Eytan I Stern, MS, RD, LD/N, CNSC
• Email: eis43@miami.edu
• Phone: 305-243-6405

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.