Effect of Statins on Crohn's Disease
Early Phase 1 · Testing Rosuvastatin · 1 site · Stanford University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Rosuvastatin (a drug) to see if it can prevent disease or complications. Condition(s) listed: Crohn's Ileocolitis and Crohn Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Early Phase 1 studies are very small first studies in people, mainly checking safety and how the body handles a treatment.
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- Established diagnosis of stricturing Crohn's disease
- Scheduled for surgical resection of terminal ileum strictures at either
- Stanford University, or
Plus 1 more requirement(s). There are also 15 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2024-12-12.
- Main results expected around 2027-10-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Rutgeerts score (6-12 months post surgery)
In the researchers’ words
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?
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Early Phase 1 |
| Study type | Interventional |
| Conditions | Crohn's Ileocolitis; Crohn Disease |
| Lead sponsor | Stanford University |
| Enrollment | 20 (estimated) |
| Start date | 2024-12-12 |
| Primary completion (est.) | 2027-10-31 |
| First posted | 2024-08-06 |
| Last updated | 2026-02-27 |
| Official title | Determining the Therapeutic Potential of Statins on Stricturing Crohn's Disease |
| ClinicalTrials.gov ID | NCT06538649 |
Interventions
- Rosuvastatin (Drug)
Rosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication. - Placebo (Other)
Placebo tablet(s)
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University | Stanford, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.