Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorStanford University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Rosuvastatin
DrugRosuvastatin 20 mg tablet once daily by mouth
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Rosuvastatin therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in bile acid (BA) profile: total bile acid
BA profile of biliary/intestinal aspirate and/or feces in response to statin therapy.
Time frame
Baseline and week 122
Change in bile acid (BA) profile: secondary bile acids:primary bile acids ratio
BA profile of biliary/intestinal aspirate and/or feces in response to statin therapy.
Time frame
Baseline and week 123
Change in bile acid (BA) profile: conjugated:unconjugated BAs ratio
BA profile of biliary/intestinal aspirate and/or feces in response to statin therapy.
Time frame
Baseline and week 124
Change in pathogen density in the small intestine
Measure impact of statin therapy upon pathogen density (ratio of good bacteria to pathogenic bacteria) within the microbial community of the duodenum.
Time frame
Baseline and week 12Secondary outcomes
1
Change in bile acid (BA) profile: total bile acid
BA profile of biliary/intestinal aspirate and/or feces in response to statin therapy.
Time frame
Baseline, week 4, week 142
Change in bile acid (BA) profile: secondary bile acids:primary bile acids ratio
BA profile of biliary/intestinal aspirate and/or feces in response to statin therapy.
Time frame
Baseline, week 4, week 143
Change in bile acid (BA) profile: conjugated:unconjugated BAs ratio
BA profile of biliary/intestinal aspirate and/or feces in response to statin therapy.
Time frame
Baseline, week 4, week 144
Change in pathogen density in the small intestine
Measure impact of statin therapy upon pathogen density (ratio of good bacteria to pathogenic bacteria) within the microbial community of the duodenum.
Time frame
Baseline, week 4, week 14Sponsors and contacts
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Source ClinicalTrials.gov