Effect of Statins on Crohn's Disease
Determining the Therapeutic Potential of Statins on Stricturing Crohn's Disease
Stanford University
20 participants
Dec 12, 2024
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
Inclusion Criteria4
- Established diagnosis of stricturing Crohn's disease
- Scheduled for surgical resection of terminal ileum strictures at either
- Stanford University, or
- Dr. Phillip Fleshner's colorectal surgery practice in Los Angeles
Exclusion Criteria15
- Pregnant, nursing, or planning to become pregnant in the next 6-12 months
- Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD))
- Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)
- Current use of cyclosporine
- Current use of statin therapy prior to study initiation
- Clinical diagnosis of active liver disease (beyond metabolic dysfunction-associated steatotic liver disease (MASLD)) with unexplained persistent elevations in hepatic transaminase levels
- 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
Interventions
Rosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication.
Placebo tablet(s)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06538649