Effect of Statins on Crohn's Disease

Stanford University

Status and phase: Enrolling; Early Phase 1

Conditions: Crohn's Ileocolitis; Crohn Disease

Treatments: Other: Placebo; Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT06538649

76686

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Statin

Experimental group

Description:

Rosuvastatin tablet(s) once daily for 6-12 months. Dose will start at 10 mg daily (5 mg daily for Asians), then increase to 20 mg for those tolerating and without contraindication.

Treatment:

Drug: Rosuvastatin

Control

Placebo Comparator group

Description:

Placebo tablet(s) taken once daily for 6-12 months.

Treatment:

Other: Placebo