[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05912387":3,"trial-entities:NCT05912387":112,"trial-summary:NCT05912387":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":52,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":86,"locations":89,"central_contacts":103,"overall_officials":106,"references":110,"see_also_links":111},"NCT05912387","67292","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","RECRUITING","2027-12-31","2026-02","2026-02-27","2023-05-31","Stanford University","OTHER",false,"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","Database studies have suggested that use of statins is associated with lower mortality in patients with PSC. Statins are also safe, widely used medications for the treatment of high cholesterol. This track record of safety makes repurposing statins for use in PSC an attractive option.\n\nThis study will evaluate the impact of bile acid profile and the microbiome. Rosuvastatin induced changes in cell signaling pathways in the body, as well as its impact of bacterial gene expression in the microbiome will be evaluated. The investigators anticipate that this study will provide key insights into the biologic basis of PSC, which may aid in the development of drugs for the treatment of PSC.\n\nThis research study will enroll patients with PSC. The study will be conducted in 3 phases: baseline measurements, study period (treatment with rosuvastatin), and follow-up (follow-up after completing statin treatment). All patients will receive the study drug, and no patients will receive placebo treatment. Rosuvastatin is FDA approved for treatment of high cholesterol, but its use in this trial is off label.",[19,20],"Primary Sclerosing Cholangitis","Inflammatory Bowel Diseases",[22],"Statin","INTERVENTIONAL","BASIC_SCIENCE",[26],"EARLY_PHASE1",{"count":28,"type":29},15,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Rosuvastatin","Rosuvastatin 20 mg tablet once daily by mouth",[36],"Rosuvastatin therapy",[38,42,44,46,49],{"measure":39,"description":40,"timeFrame":41},"Change in bile acid (BA) profile: total bile acid","BA profile of biliary\u002Fintestinal aspirate and\u002For feces in response to statin therapy.","Baseline and week 12",{"measure":43,"description":40,"timeFrame":41},"Change in bile acid (BA) profile: secondary bile acids:primary bile acids ratio",{"measure":45,"description":40,"timeFrame":41},"Change in bile acid (BA) profile: conjugated:unconjugated BAs ratio",{"measure":47,"description":48,"timeFrame":41},"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.",{"measure":50,"description":51,"timeFrame":41},"Change in bacterial gene expression profile in the small intestine","This outcome aims to develop an understanding of the profile of microbial metabolic pathways in the duodenum and changes to the profile in response to statin therapy; gene sequencing with be done using shotgun metagenomics followed by pathway analysis.",[53,55,56,57,58],{"measure":39,"description":40,"timeFrame":54},"Baseline, week 4, week 14",{"measure":43,"description":40,"timeFrame":54},{"measure":45,"description":40,"timeFrame":54},{"measure":47,"description":48,"timeFrame":54},{"measure":50,"description":51,"timeFrame":54},"ALL","18 Years","80 Years",true,{"inclusion":64,"exclusion":68,"raw_text":85},[65,66,67],"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 \\\u003C 25.0 for the comparison arm",[69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84],"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\u002FdL","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","Inclusion Criteria:\n\n* Males and females, greater than or equal to 18 years of age\n* 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\n* Hypercholesterolemia with BMI \\\u003C 25.0 for the comparison arm\n\nExclusion Criteria:\n\n* Diagnosis of PSC-autoimmune hepatitis overlap syndrome\n* Woman who are pregnant, nursing, or expect to be pregnant\n* 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\n* Diagnosis of a serious medical condition (unless approved in writing by a physician)\n* Patients taking statin therapy prior to study initiation\n* Patients with known clinically allergy to statin therapy\n* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times the upper limit of normal\n* Bilirubin greater than 3.0 mg\u002FdL\n* Recent use of antibiotics (within the last 90 days)\n* Concurrent use of any immunosuppressive medications (such as any calcineurin inhibitor, steroids at a dose greater than 10 mg of prednisone-equivalents per day)\n* Actively using a fibrate drug\n* Actively using a ritonavir containing drug\n* Familial hypercholesterolemia or other inherited disorder of lipid metabolism\n* Recent myocardial infarction or cerebrovascular accident\n* Body mass index \\> 25.0 for the comparison arm\n* Chronic kidney disease stage 5 or end-stage renal disease",[87,88],"ADULT","OLDER_ADULT",[90],{"facility":13,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":100},"Stanford","California","94305","United States",[96],{"name":97,"role":98,"email":99},"Touran Fardeen","CONTACT","tfardeen@stanford.edu",{"lat":101,"lon":102},37.42411,-122.16608,[104],{"name":97,"role":98,"phone":105,"email":99},"(650) 725-5890",[107],{"name":108,"affiliation":13,"role":109},"Sidhartha Sinha, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":113,"biomarkers":115},[114,19],"Inflammatory Bowel Disease",[],{"nct_id":4,"found":62,"summary":117,"prompt_version":127},{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is an interventional study where all 15 participants will receive rosuvastatin 20 mg once daily. There is no placebo group in this study.","completed","Rosuvastatin for Primary Sclerosing Cholangitis (PSC)","This study is investigating if rosuvastatin, a common cholesterol medication, can help people with Primary Sclerosing Cholangitis (PSC), a liver disease with no current cure. Researchers want to understand how rosuvastatin affects bile acids (substances made by the liver) and the gut microbiome (the bacteria in your intestines) in PSC patients. You may be able to join if you are 18 to 80 years old and have a confirmed diagnosis of PSC, often along with inflammatory bowel disease (IBD). The main goal is to see changes in your bile acid profile after 12 weeks of taking rosuvastatin. This study hopes to provide important insights that could lead to new treatments for PSC. The study plans to enroll 15 participants, but its current status is unclear.","You will have follow-up after completing statin treatment. Bile acid changes will be measured at baseline and week 12.",125,"You will have baseline measurements, take rosuvastatin for a period, and then have follow-up after treatment. Specific details about visits or procedures are not provided.","Not stated in the trial record.",[33],"v2"]