[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569813":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":37,"locations":43,"responsibleParty":155,"collaborators":30,"id":157,"slug":30,"hasResults":158,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":30,"eligibilityCriteria":162,"healthyVolunteers":158,"sex":163,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":30,"studyType":169,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":80,"whyStopped":30,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"LISCure Biosciences","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"LB-P8 low-dose","EXPERIMENTAL","Oral capsule, 1×10\\^10 CFU\u002Fday",[13],"Drug: LB-P8 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Trials","CONTACT","+82317061710","clinical@liscure.bio",[44,63,78,94,109,124,139],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University of California Davis","NOT_YET_RECRUITING","Sacramento","California","95817","United States",{"type":52,"coordinates":53},"Point",[54,55],-121.4944,38.58157,{"lat":55,"lon":54},[58,60],{"name":45,"role":40,"phone":59,"phoneExt":30,"email":30},"800-282-3284",{"name":61,"role":62,"phone":30,"phoneExt":30,"email":30},"Christopher Bowlus, MD","PRINCIPAL_INVESTIGATOR",{"facility":64,"status":46,"city":65,"state":66,"zip":67,"country":50,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"UCHealth University of Colorado Hospital","Aurora","Colorado","80045",{"type":52,"coordinates":69},[70,71],-104.83192,39.72943,{"lat":71,"lon":70},[74,76],{"name":64,"role":40,"phone":75,"phoneExt":30,"email":30},"7208480000",{"name":77,"role":62,"phone":30,"phoneExt":30,"email":30},"Lisa Forman, 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Clinic","Rochester","Minnesota","55905",{"type":52,"coordinates":115},[116,117],-92.4699,44.02163,{"lat":117,"lon":116},[120,122],{"name":110,"role":40,"phone":121,"phoneExt":30,"email":30},"507-284-2511",{"name":123,"role":62,"phone":30,"phoneExt":30,"email":30},"John Eton, MD",{"facility":125,"status":80,"city":126,"state":127,"zip":128,"country":50,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"The Vanderbilt Clinic","Nashville","Tennessee","37232",{"type":52,"coordinates":130},[131,132],-86.78444,36.16589,{"lat":132,"lon":131},[135,137],{"name":125,"role":40,"phone":136,"phoneExt":30,"email":30},"615-322-5000",{"name":138,"role":62,"phone":30,"phoneExt":30,"email":30},"Manhal Izzy, MD",{"facility":140,"status":80,"city":141,"state":142,"zip":143,"country":50,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Liver institute Northwest","Seattle","Washington","98105",{"type":52,"coordinates":145},[146,147],-122.33207,47.60621,{"lat":147,"lon":146},[150,153],{"name":140,"role":40,"phone":151,"phoneExt":30,"email":152},"206-536-3030","info@liverinstitutenw.org",{"name":154,"role":62,"phone":30,"phoneExt":30,"email":30},"Kris Kowdley, MD",{"type":156,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100569813",false,"NCT06699121","A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC","A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Study Evaluating the Safety and Efficacy of LB P8 in Patients With Primary Sclerosing Cholangitis (PSC)","Inclusion Criteria:\n\n* Age: 18 to 75 years\n* A diagnosis of PSC based on cholangiographic evidence of PSC in accordance with American Association for the Study of Liver Diseases (AASLD) guidelines\n* ALP \\>1.5 times the ULN at screening\n* PSC with or without IBD, such as ulcerative colitis or Crohn's disease\n* If patients are being administered biologic or advanced therapeutic treatments, immunosuppressants, systemic corticosteroids, obeticholic acid, fibrates, or statins, they must be on a stable dose for ≥3 months prior to, and including, Day 0 and plan to remain on a stable dose throughout the study\n* If patients are receiving ursodeoxycholic acid, they must be on a stable dose (not exceeding 23 mg\u002Fkg\u002Fday) for \\>3 months prior to screening\n* Patient agrees to stop all probiotics for at least 2weeks prior to treatment\n* Patient is unable to conceive and\u002For patient who's partner is unable to become pregnant and\u002For agree to use effective methods of contraception when engaging in heterosexual intercourse\n\nExclusion Criteria:\n\n* Treatment with any investigational agents within 3 months or 5 half-lives, whichever is longer prior to treatment or during the study. Gene therapy or other long-lasting investigational agents with unknown half-life is not allowed\n* History of a liver transplant or anticipated need for a liver transplant within 1 year\n* Patients who show evidence of significant worsening of hepatic function will be excluded.\n* Evidence of compensated or decompensated cirrhosis based on histology, relevant medical complications, or laboratory parameters\n* Model for end-stage liver disease (MELD) score as below, unless the MELD is driven by anticoagulant therapy, vitamin deficiency, or kidney disease:\n* MELD Score of \\>12 (decompensated cirrhosis) for Part 1 of the study\n* MELD Score of \\>12 for Part 2 of the study\n* Small-duct PSC (in the absence of large duct PSC)\n* Secondary causes of sclerosing cholangitis including IgG4 associated sclerosing cholangitis\n* Any history of cholangiocarcinoma, gallbladder cancer, or hepatocellular carcinoma\n* History of any malignancy with lymph node or regional metastases within 5 years or current malignancy undergoing active treatment\n* Patients who require chronic use of antibiotics, received antibiotics in the last 1 month, or received Rebyota or Vowst (applicable for patients with Clostridioides difficile infection)\n* In patients with ulcerative colitis, partial Mayo score of \\>6 or, patients with Crohn's disease if CDAI of \\>220\n* Chronic kidney injury\n* Recent acute cholangitis (within 90 days)\n* Patients with indwelling biliary drain (or stent), total proctocolectomy with ileal anal pouch, partial large bowel resections or history of small bowel resection\n* Other causes of liver disease, such as autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), AIH\u002FPSC overlap syndrome, alpha-1-antitrypsin deficiency, viral hepatitis, iron overload syndrome, Wilson disease, nonalcoholic steatohepatitis, and\u002For alcohol related liver disease. Additionally, positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV) (detectable HCV RNA in the serum), or human immunodeficiency virus antibodies (anti HIV)\n* Active drug (known or suspected use of illicit drugs or drugs of abuse) or alcohol abuse disorder\n* Female patients who are pregnant, nursing, or planning to become pregnant during the study\n* Clinically significant and\u002For active infection\n* Subjects with a greater degree of immunosuppression, as evidenced by Alsolute neutrophil count \\\u003C500 cells\u002FmL or in the investigator's judgement immunosuppressed and at higher risk of infection","ALL","18 Years","75 Years",{"count":167,"type":168},87,"ESTIMATED","INTERVENTIONAL",[171],"PHASE2","The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.",[174],"Primary Sclerosing Cholangitis (PSC)",[176,177,178,179,180,181],"PSC","Pruritus","Inflammatory bowel disease","IBD","Itch","Cholestasis","2025-10-22",{"date":184,"type":185},"2025-10-24","ACTUAL",{"date":187,"type":168},"2025-11",{"date":189,"type":168},"2029-02",{"name":5,"class":6},7]