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

Description

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

Conditions

Primary Sclerosing Cholangitis, Inflammatory Bowel Diseases

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Primary Sclerosing Cholangitis
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford University, Stanford, California, United States, 94305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Stanford University,

Sidhartha Sinha, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2025-12-31