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Effect of Statins on Crohn's Disease

NCT06538649 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-27

No results posted yet for this study

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

Conditions

  • Crohn's Ileocolitis
  • Crohn Disease

Interventions

DRUG

Rosuvastatin

Rosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication.

OTHER

Placebo

Placebo tablet(s)

Sponsors & Collaborators

Principal Investigators

  • Sidhartha R Sinha, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2027-10-31
Completion
2028-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06538649 on ClinicalTrials.gov