Effect of Statins on Crohn's Disease

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 morbidity and hospital admissions and is frequently associated with treatment failures. Moreover, it is estimated that nearly 50% of patients with CD will undergo bowel resection surgery within ten years of diagnosis, highlighting the severity and persistence of this issue for patients as well as the healthcare system.

By modulating inflammatory and fibrotic pathways, the investigators posit that statins reduce primary stricture development and also recurrence after stricture resection.

The investigators will assess the impact of statin therapy on early stricture recurrence in a pilot, randomized controlled clinical trial in patients undergoing stricture resection, evaluating both clinical outcomes and detailed immune, microbiome, and metabolic profiling. Through this effort, the investigators will determine if statins reduce clinical and biological signs of stricture recurrence in the short term.

Inclusion criteria

• 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 criteria

• 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