Effect of Statins on Crohn's Disease

NCT ID: NCT06538649

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-12
• Study Completion Date: 2028-10-31

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.

Conditions

Crohn's Ileocolitis; Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Statin

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.

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

Rosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication.

Control

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo tablet(s)

Interventions

Rosuvastatin

Rosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication.

Intervention Type: DRUG

Placebo

Placebo tablet(s)

Intervention Type: OTHER

Other Intervention Names

Crestor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sidhartha Ranjit Sinha

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sidhartha R Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Touran Fardeen

Role: CONTACT

tfardeen@stanford.edu

650-736-5555

Facility Contacts

Sidhartha Sinha, MD

Role: primary

sidsinha@stanford.edu

650-736-5555

Other Identifiers

76686

Identifier Type: -

Identifier Source: org_study_id