The Effect of Statin Therapy on Bile Acid Physiology and the Microbiome in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

PSC is a liver disease that has no medical cure. Patients with PSC are at a greatly increased risk of cancer and infection. Additionally, many patients require a liver transplant. Progress towards a cure has been severely limited by an incomplete understanding of why patients develop PSC. The investigators aim to close this gap by conducting a pilot human study in patients with PSC, using statin therapy as a model

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
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• Males and females, greater than or equal to 18 years of age

• Established diagnosis of PSC, defined by either appropriate cholangiographic findings or supportive liver biopsy plus an established diagnosis of inflammatory bowel disease (IBD - Crohn's disease or ulcerative colitis) per American College of Gastroenterology (ACG) guidelines for the PSC-IBD arm

• Hypercholesterolemia with BMI \< 25.0 for the comparison arm

Locations
United States
California
Stanford University
RECRUITING
Stanford
Contact Information
Primary
Touran Fardeen
tfardeen@stanford.edu
(650) 725-5890
Time Frame
Start Date: 2023-05-31
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 15
Treatments
Experimental: Rosuvastatin therapy
Participants will receive rosuvastatin for 12 weeks followed by a 2 week washout period prior to the final follow-up visit. All patients will receive the study drug, and will serve as their own control. No participants will receive placebo. Rosuvastatin is FDA approved for treatment of high cholesterol, but its use in this trial is off label.
Sponsors
Leads: Stanford University

This content was sourced from clinicaltrials.gov