Crohn Disease, Crohn's Ileocolitis
Conditions
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
Detailed 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 reduce primary stricture development and also recurrence after stricture resection. The investigators will assess the impact of statin therapy on early stricture recurrence in a pilot, randomized controlled clinical trial in patients undergoing stricture resection, evaluating both clinical outcomes and detailed immune, microbiome, and metabolic profiling. Through this effort, the investigators will determine if statins reduce clinical and biological signs of stricture recurrence in the short term.
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)
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Random assignment (2:1) to either statin (Arm 1) or placebo (Arm 2), such that 2/3 of participants will be assigned to Arm 1, and 1/3 of participants will be assigned to Arm 2.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rutgeerts score | 6-12 months post surgery | Will be assessed at post surgery surveillance colonoscopy. Minimum score is i0 (no lesions) and maximum score is i4 (diffuse inflammation with already larger ulcers, nodules and/or narrowing), with higher scores meaning a worse outcome. |
Countries
United States
Contacts
CONTACTTouran Fardeen
PRINCIPAL_INVESTIGATORSidhartha R Sinha, MD
Stanford University
Outcome results
None listed