Effect of Statins on Crohn's Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorStanford University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Rosuvastatin
DrugRosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication.
Placebo
Other interventionPlacebo tablet(s)
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: StatinExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rutgeerts score
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.
Time frame
6-12 months post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov