Using statins to prevent strictures in Crohn's disease
Determining the Therapeutic Potential of Statins on Stricturing Crohn's Disease
This study is testing if taking statins can help adults with Crohn's disease avoid getting strictures after surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT06538649 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with an established diagnosis of stricturing Crohn's disease who are scheduled for surgical resection of terminal ileum strictures.
Not a fit: Patients who are pregnant, have severe renal dysfunction, or have a known allergy to statins may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment option for patients with Crohn's disease, potentially reducing the need for surgery.
How similar studies have performed: While the use of statins in this context is novel, previous studies have suggested potential benefits of statins in modulating inflammatory pathways, though this specific application is less explored.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stanford, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.