RECRUITING

Effect of Statins on Crohn's Disease

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Conditions

Crohn's IleocolitisCrohn Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Determining the Therapeutic Potential of Statins on Stricturing Crohn's Disease

Quick Facts

Study Start:2024-12-12
Study Completion:2028-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06538649

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Established diagnosis of stricturing Crohn's disease
  2. 2. Scheduled for surgical resection of terminal ileum strictures at either
  3. * Stanford University, or
  4. * Dr. Phillip Fleshner's colorectal surgery practice in Los Angeles
  1. 1. Pregnant, nursing, or planning to become pregnant in the next 6-12 months
  2. 2. Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD))
  3. 3. Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)
  4. 4. Current use of cyclosporine
  5. 5. Current use of statin therapy prior to study initiation
  6. 6. Clinical diagnosis of active liver disease (beyond metabolic dysfunction-associated steatotic liver disease (MASLD)) with unexplained persistent elevations in hepatic transaminase levels
  7. 7. Current use of any of the following medications, without explicit clearance from a treating physician to enroll in the study:
  8. * Antifungals (e.g., ketoconazole, itraconazole, voriconazole)
  9. * Fibrate drugs
  10. * Macrolide antibiotics (e.g., erythromycin, clarithromycin)
  11. * Protease inhibitors (e.g., ritonavir, lopinavir)
  12. * Calcium channel blockers (e.g., verapamil, diltiazem)
  13. * Amiodarone
  14. * Warfarin
  15. * Colchicine

Contacts and Locations

Study Contact

Touran Fardeen
CONTACT
650-736-5555
tfardeen@stanford.edu

Principal Investigator

Sidhartha R Sinha, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University
Stanford, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Sidhartha R Sinha, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-12
Study Completion Date2028-10-31

Study Record Updates

Study Start Date2024-12-12
Study Completion Date2028-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Crohn's Ileocolitis
  • Crohn Disease