Effect of Statins on Crohn's Disease

Official title

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

Overview

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

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 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.

Interventions

• 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)

Primary outcome measures

• Rutgeerts score [Time frame: 6-12 months post surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Stanford University — Stanford

Identifiers

NCT: NCT06538649 · 76686

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗