Effect of Statins on Crohn's Disease

Early Phase 1

Recruiting

• Conditions: Crohn's Ileocolitis; Crohn Disease
• Interventions: Drug: Rosuvastatin; Other: Placebo

• Registration Number: NCT06538649
• Lead Sponsor: Stanford University

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 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.

Study Timeline

• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-01
• Study First Posted: 2024-08-06
• Status Verified: 2024-12
• Study Start: 2024-12-12
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-10-31
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statin	Rosuvastatin	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.
Control	Placebo	Placebo tablet(s) taken once daily for 6-12 months.

Primary Outcome Measures

Name	Time	Method
Rutgeerts score	6-12 months post surgery	Will be assessed at post surgery surveillance colonoscopy. Minimum score is i0 (no lesions) and maximum score is i4 (diffuse inflammation with already larger ulcers, nodules and/or narrowing), with higher scores meaning a worse outcome.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States