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Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study

RecruitingEarly phase 1Healthy volunteers welcome

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

Who can join

Ages 18 to 80 · All sexes · Healthy volunteers welcome

Full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* Diagnosis of PSC-autoimmune hepatitis overlap syndrome
* Woman who are pregnant, nursing, or expect to be pregnant
* The presence of any comorbidity known to cause secondary sclerosing cholangitis, including: immunoglobulin G-4 (IgG4), associated cholangitis, recurrent bacterial cholangitis, recurrent pyogenic cholangitis, ischemic cholangiopathy, surgical biliary trauma, cholangiocarcinoma, and portal hypertensive biliopathy
* Diagnosis of a serious medical condition (unless approved in writing by a physician)
* Patients taking statin therapy prior to study initiation
* Patients with known clinically allergy to statin therapy
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times the upper limit of normal
* Bilirubin greater than 3.0 mg/dL
* Recent use of antibiotics (within the last 90 days)
* Concurrent use of any immunosuppressive medications (such as any calcineurin inhibitor, steroids at a dose greater than 10 mg of prednisone-equivalents per day)
* Actively using a fibrate drug
* Actively using a ritonavir containing drug
* Familial hypercholesterolemia or other inherited disorder of lipid metabolism
* Recent myocardial infarction or cerebrovascular accident
* Body mass index \> 25.0 for the comparison arm
* Chronic kidney disease stage 5 or end-stage renal disease

About the study

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

What is being tested

Sponsor: Stanford University · Participants: 15 · Started: May 31, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05912387

Locations in the U.S.

CaliforniaStanford University, Stanford

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.