Crohn's Ileocolitis study: Rosuvastatin
Official title Effect of Statins on Crohn's Disease
ClinicalTrials.gov ID: NCT06538649
What this study is testing
What is Rosuvastatin?
An investigational medicine being studied to see if it can help prevent bowel narrowing in adults with Crohn's disease. is designed to lower cholesterol and may affect the body's inflammatory and fibrotic pathways.
Also referred to as Crestor.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether statins can reduce the formation of strictures in people with Crohn's disease.
- Who it's for
- You may be able to join if you are an adult with Crohn's disease that can develop strictures.
- What's involved
- You will take a statin pill or a pretend pill every day for 6 to 12 months. You will visit the clinic twice for lab tests, fill out symptom questionnaires, and answer monthly phone calls.
- Time commitment
- The study lasts up to 12 months and includes two clinic visits, monthly phone check‑ins, and daily pill taking.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- Pregnant, nursing, or planning to become pregnant in the next 6-12 months
- Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD))
- Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)
- Current use of cyclosporine
- Current use of statin therapy prior to study initiation
- Clinical diagnosis of active liver disease (beyond metabolic dysfunction-associated steatotic liver disease (MASLD)) with unexplained persistent...
See the full eligibility criteria
- 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
- Pregnant, nursing, or planning to become pregnant in the next 6-12 months
- Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD))
- Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)
- Current use of cyclosporine
- Current use of statin therapy prior to study initiation
- Clinical diagnosis of active liver disease (beyond metabolic dysfunction-associated steatotic liver disease (MASLD)) with unexplained persistent elevations in hepatic transaminase levels
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Stanford, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.