Effect of Statins on Crohn's Disease

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT06538649
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rosuvastatin — DRUG
    Rosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication.
  • Placebo — OTHER
    Placebo tablet(s)

Study Details

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

Key Dates

Start date
Dec 12, 2024
Status verified
Feb 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Statin
    Rosuvastatin tablet(s) once daily for 6-12 months. Dose will start at 10 mg daily (5 mg daily for Asians), then increase to 20 mg for those tolerating and without contraindication.
  • Placebo Comparator: Control
    Placebo tablet(s) taken once daily for 6-12 months.

Primary Outcome Measure

Rutgeerts score [ Time Frame: 6-12 months post surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Sidhartha Sinha, MD
[email protected]
650-736-5555
Sidhartha Sinha, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Stanford, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Stanford University· Stanford, CA

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