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NCT07671872Recruiting

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

Targeting Gut Inflammation Through Diet: a Tailored American Diet for Patients With Crohn's Disease

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
122 (estimated)
First submitted
22 Jun 2026
Start date
16 Sept 2026
Primary completion date
Aug 2030
Lead sponsor
University of Miami
NCT number
NCT07671872

What you commit to

  • Study type: Interventional
  • Planned participants: 122
  • From 16 Sept 2026 to the primary completion date, Aug 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior J pouch or diversion
  • 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

Other illness

  • Recent inflammatory bowel disease (IBD) related hospitalizations in the last 4 weeks
  • Clostridium difficile or enteric infections in the last 4 weeks
  • Active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)

Age

  • Ages \< 16 and \> 75 years old

Other

  • Diagnosis of Ulcerative Colitis (UC).
  • Use of probiotics in the last 4 weeks
  • Patients following the specific carbohydrate diet or Mediterranean diet or anti-inflammatory diet
  • 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
  • Prisoners

Who the study is looking for

  • 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

Age in the registry: 16 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Miami
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.