RECRUITINGEarly Phase 1INTERVENTIONAL

Effect of Statins on Crohn's Disease

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

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 1. Established diagnosis of stricturing Crohn's disease 2. Scheduled for surgical resection of terminal ileum strictures at either - Stanford University, or - Dr. Phillip Fleshner's colorectal surgery practice in Los Angeles Who Should NOT Join This Trial: 1. Pregnant, nursing, or planning to become pregnant in the next 6-12 months 2. Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD)) 3. Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis) 4. Current use of cyclosporine 5. Current use of statin therapy prior to study initiation 6. Clinical diagnosis of active liver disease (beyond metabolic dysfunction-associated steatotic liver disease (MASLD)) with unexplained persistent elevations in hepatic transaminase levels 7. Current use of any of the following medications, without explicit clearance from a treating physician to enroll in the study: - Antifungals (e.g., ketoconazole, itraconazole, voriconazole) - Fibrate drugs - Macrolide antibiotics (e.g., erythromycin, clarithromycin) - Protease inhibitors (e.g., ritonavir, lopinavir) - Calcium channel blockers (e.g., verapamil, diltiazem) - Amiodarone - Warfarin - Colchicine Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Established diagnosis of stricturing Crohn's disease 2. Scheduled for surgical resection of terminal ileum strictures at either * Stanford University, or * Dr. Phillip Fleshner's colorectal surgery practice in Los Angeles Exclusion Criteria: 1. Pregnant, nursing, or planning to become pregnant in the next 6-12 months 2. Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD)) 3. Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis) 4. Current use of cyclosporine 5. Current use of statin therapy prior to study initiation 6. Clinical diagnosis of active liver disease (beyond metabolic dysfunction-associated steatotic liver disease (MASLD)) with unexplained persistent elevations in hepatic transaminase levels 7. Current use of any of the following medications, without explicit clearance from a treating physician to enroll in the study: * Antifungals (e.g., ketoconazole, itraconazole, voriconazole) * Fibrate drugs * Macrolide antibiotics (e.g., erythromycin, clarithromycin) * Protease inhibitors (e.g., ritonavir, lopinavir) * Calcium channel blockers (e.g., verapamil, diltiazem) * Amiodarone * Warfarin * Colchicine

Treatments Being Tested

DRUG

Rosuvastatin

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

OTHER

Placebo

Placebo tablet(s)

Locations (1)

Stanford University

Stanford, California, United States