Using statins to prevent strictures in Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine if statins can prevent the formation of strictures in adults with stricturing Crohn's disease. Participants will be randomly assigned to receive either statins or a placebo daily for 6-12 months. The study will involve clinic visits for lab tests, completion of symptom questionnaires, and monthly phone check-ins. By evaluating clinical outcomes and biological markers, the researchers hope to assess the effectiveness of statins in reducing stricture recurrence after surgical resection.

Why it matters

Who can join: the full rules

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

Where it's running

• Stanford University
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Sidhartha R Sinha, MD — Stanford University
• Study coordinator: Touran Fardeen
• Email: tfardeen@stanford.edu
• Phone: 650-736-5555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.