Effect of Statins on Crohn's Disease

Description

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

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Study Overview

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Study Details

Study overview

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

Determining the Therapeutic Potential of Statins on Stricturing Crohn's Disease

Effect of Statins on Crohn's Disease

Condition
Crohn's Ileocolitis
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford University, Stanford, California, United States, 94305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Sidhartha R Sinha, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2028-10-31