Effect of Statins on Crohn's Disease

Last updated: April 14, 2025
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

1

Condition

Crohn's Disease (Pediatric)

Treatment

Placebo

Rosuvastatin

Clinical Study ID

NCT06538649
76686
  • Ages 18-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

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 renaldisease (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-associatedsteatotic liver disease (MASLD)) with unexplained persistent elevations in hepatictransaminase levels

  7. Current use of any of the following medications, without explicit clearance from atreating 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

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
December 12, 2024
Estimated Completion Date:
October 31, 2028

Study 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.

Connect with a study center

  • Stanford University

    Stanford, California 94305
    United States

    Active - Recruiting

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