Clinical trial NCT06538649: Effect of Statins on Crohn's Disease
Official title: Determining the Therapeutic Potential of Statins on Stricturing Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Crohn's Ileocolitis
Crohn Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rutgeerts score
timeFrame: 6-12 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Sidhartha R Sinha, MD
role: PRINCIPAL_INVESTIGATOR
References: