NCT06538649 Effect of Statins on Crohn's Disease
| NCT ID | NCT06538649 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Stanford University |
| Condition | Crohn's Ileocolitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-12-12 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Sidhartha R Sinha, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT06538649 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Crohn's Ileocolitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06538649 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06538649 currently recruiting?
Yes, NCT06538649 is actively recruiting participants. Contact the research team at tfardeen@stanford.edu for enrollment information.
Where is the NCT06538649 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT06538649 clinical trial?
NCT06538649 is sponsored by Stanford University. The principal investigator is Sidhartha R Sinha, MD at Stanford University. The trial plans to enroll 20 participants.