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RecruitingEarly Phase 1

Effect of Statins on Crohn's Disease

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether statins can prevent strictures, or narrowed areas in the bowel, in adults with Crohn's disease. It is for people with strictures who are scheduled for surgery. Participants will take a statin or a placebo (a look-alike pill with no drug) each day for 6–12 months.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You have been diagnosed with Crohn's disease that causes narrowed areas in the bowel.
  • You are scheduled for surgery to remove narrowed areas at the end of your small intestine at Stanford University or Dr. Phillip Fleshner's colorectal surgery practice in Los Angeles.

Who can't join

  • You are pregnant, breastfeeding, or planning to become pregnant in the next 6–12 months.
  • You have stage 5 chronic kidney disease or end-stage kidney disease, meaning your kidneys have very little or no function.
  • You have a known allergy to statins or have had a harmful reaction to them, such as severe muscle breakdown.
  • You currently take cyclosporine.
  • You already take a statin before the study starts.
  • You have active liver disease beyond MASLD (a type of fatty liver disease), with liver blood test levels that stay high for an unknown reason.
  • You take any of these medicines without clear approval from your treating doctor to join: antifungal medicines (such as ketoconazole, itraconazole, or voriconazole); fibrates; macrolide antibiotics (such as erythromycin or clarithromycin); protease inhibitors (such as ritonavir or lopinavir); calcium channel blockers (such as verapamil or diltiazem); amiodarone; warfarin; or colchicine.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA