Recruiting
Early Phase 1

Statins

Sponsor:

Stanford University

Code:

NCT06538649

Conditions

Crohn's Ileocolitis

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rosuvastatin

Placebo

Study Details

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

Conditions

Crohn's Ileocolitis

Crohn Disease

Study ID

NCT06538649

Start date

Dec 12, 2024

Status verified date

Feb, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: Control

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

Interventions

Rosuvastatin

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

Placebo

Placebo tablet(s)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Principal Investigator:

Sidhartha Sinha, MD

More Information

Sponsor

Stanford University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-02-27.