Actively Recruiting

Early Phase 1
Age: 18Years - 80Years
All Genders
NCT06538649

Effect of Statins on Crohn's Disease

Led by Stanford University · Updated on 2026-02-27

20

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if statins work to prevent strictures in adults with Crohn's disease. The main question it aims to answer is: * Can statins reduce the formation of strictures in participants with stricturing Crohn's disease? Researchers will compare statins to a placebo (a look-a-like substance that contains no drug) to see if statins work to prevent strictures from forming. Participants will: * Take statins or a placebo every day for 6-12 months * Visit the clinic for lab tests twice after starting either statins or placebo * Complete questionnaires about symptoms and medications * Respond to monthly check-ins (via phone call) during participation

CONDITIONS

Official Title

Effect of Statins on Crohn's Disease

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Established diagnosis of stricturing Crohn's disease
  • Scheduled for surgical resection of terminal ileum strictures at Stanford University or Dr. Phillip Fleshner's colorectal surgery practice in Los Angeles
Not Eligible

You will not qualify if you...

  • Pregnant, nursing, or planning to become pregnant in the next 6-12 months
  • Severe renal dysfunction (stage 5 chronic kidney disease or end-stage renal disease)
  • Known allergy or prior serious reaction to statin therapy (e.g., rhabdomyolysis)
  • Current use of cyclosporine
  • Current use of statin therapy before starting the study
  • Active liver disease beyond metabolic dysfunction-associated steatotic liver disease with unexplained persistent liver enzyme elevations
  • Current use of antifungals (ketoconazole, itraconazole, voriconazole), fibrate drugs, macrolide antibiotics (erythromycin, clarithromycin), protease inhibitors (ritonavir, lopinavir), calcium channel blockers (verapamil, diltiazem), amiodarone, warfarin, or colchicine without doctor approval

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

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Research Team

T

Touran Fardeen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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