RecruitingEarly Phase 1NCT05912387

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

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

Sponsor

Stanford University

Enrollment

15 participants

Start Date

May 31, 2023

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel Diseases Primary Sclerosing Cholangitis

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

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 Criteria16

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