Status:
RECRUITING
Effect of Statins on Crohn's Disease
Lead Sponsor:
Stanford University
Conditions:
Crohn's Ileocolitis
Crohn Disease
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief 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 strictu...
Detailed Description
Strictures are a formidable complication of Crohn's disease (CD), with more than half of patients experiencing clinically significant bowel obstructions. Stricturing CD is a primary driver of morbidit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06538649
Start Date
December 12 2024
End Date
October 31 2028
Last Update
April 17 2025
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305