RecruitingEarly Phase 1NCT06538649

Effect of Statins on Crohn's Disease

Determining the Therapeutic Potential of Statins on Stricturing Crohn's Disease


Sponsor

Stanford University

Enrollment

20 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is looking at whether statin medications — commonly used to lower cholesterol — can reduce scar tissue (fibrosis) in the intestines of people with Crohn's disease. It focuses on patients who are already scheduled to have surgery to remove a narrowed section of the small intestine caused by Crohn's. **You may be eligible if...** - You have a confirmed diagnosis of Crohn's disease that causes narrowing (strictures) in the small intestine - You are scheduled for surgery to remove the narrowed section at Stanford University or a specific colorectal surgery practice in Los Angeles - You are not currently taking a statin medication **You may NOT be eligible if...** - You are pregnant, nursing, or planning to become pregnant in the next 6–12 months - You have severe kidney disease (stage 5 or end-stage) - You have had a bad reaction to statins in the past (such as muscle breakdown) - You are currently taking cyclosporine - You have active liver disease beyond fatty liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRosuvastatin

Rosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication.

OTHERPlacebo

Placebo tablet(s)


Locations(1)

Stanford University

Stanford, California, United States

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NCT06538649


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