Determining the Therapeutic Potential of Statins on Stricturing Crohn's Disease
Stanford University
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
Description
Strictures are a formidable complication of Crohn's disease (CD), with more than half of patients experiencing clinically significant bowel obstructions. Stricturing CD is a primary driver of morbidity and hospital admissions and is frequently associated with treatment failures. Moreover, it is estimated that nearly 50% of patients with CD will undergo bowel resection surgery within ten years of diagnosis, highlighting the severity and persistence of this issue for patients as well as the healthcare system. By modulating inflammatory and fibrotic pathways, the investigators posit that statins…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugRosuvastatin
Rosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication.
- OtherPlacebo
Placebo tablet(s)
Location
- Stanford UniversityStanford, California