NCT06538649RecruitingEarly phase 1
Effect of Statins on Crohn's Disease
Determining the Therapeutic Potential of Statins on Stricturing Crohn's Disease
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 1 Aug 2024
- Start date
- 12 Dec 2024
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Stanford University
- Diseases
- Crohn's disease
- NCT number
- NCT06538649
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From 12 Dec 2024 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)
- Current use of statin therapy prior to study initiation
Other illness
- Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD))
Lab values
- Clinical diagnosis of active liver disease (beyond metabolic dysfunction-associated steatotic liver disease (MASLD)) with unexplained persistent elevations in hepatic transaminase levels
- 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
Other
- Pregnant, nursing, or planning to become pregnant in the next 6-12 months
- Current use of cyclosporine
Who the study is looking for
- Established diagnosis of stricturing Crohn's disease
- Scheduled for surgical resection of terminal ileum strictures at either
- Stanford University, or
- Dr. Phillip Fleshner's colorectal surgery practice in Los Angeles
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.