[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542947":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":26,"studyPopulation":18,"armGroups":27,"interventions":44,"overallOfficials":18,"centralContacts":55,"locations":62,"responsibleParty":80,"collaborators":18,"id":84,"slug":18,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":18,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":18,"enrollmentInfo":92,"targetDuration":18,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":18,"overallStatus":65,"whyStopped":18,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Kaohsiung Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"the eradication rate of Helicobacter pylori","evalute eradication outcome by 13C urea breath test","8 week after finishing study drugs",[14],{"measure":15,"description":16,"timeFrame":17},"genotype analysis","CYP3A4, CYP2C19 and IL-1B -511 genotypes","1 day",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","1. bismuth-amoxicillin-vonoprazan triple therapy\n2. vonoprazan-amoxicillin dual therapy\n3. proton pump inhibitor-based standard triple therapy","TREATMENT",{"masking":25,"maskingDescription":18,"whoMasked":18},"NONE","For this multi-center, randomized, open-label, superiority trial, we will recruit 780 adult patients with H. pylori infection from ten medical centers or regional hospitals in Taiwan. Using a computer generated randomized sequence, we randomly allocate patients (1:1:1; block size of six) to either 14-day bismuth-amoxicillin-vonoprazan triple therapy, 14-day vonoprazan dual therapy, or 14-day rabeprazole-triple therapy. Patients are asked to return at the second week to assess drug adherence and adverse events. Post-treatment H. pylori status is assessed by 13C-urea breath test at week 6. Participants with failure of H. pylori eradication will randomly receive either 14-day vonoprazan-based or 14-day esomeprazole-based bismuth quadruple therapy. Finally, the rates of eradication and adverse events will be compared between groups by chi-square test. Additionally, the effects of antibiotic resistances of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of above first-line and second-line anti-H. pylori treatments are assessed by multivariate analysis.",[28,34,39],{"label":29,"type":30,"description":31,"interventionNames":32},"bismuth-amoxicillin-vonoprazan triple therapy","ACTIVE_COMPARATOR","vonoprazan 20mg twice a day + amoxicillin 750mg four times a day + tripotassium dicitrate bismuthate 300mg four times a day",[33],"Drug: vonoprazan, amoxicillin, tripotassium dicitrate bismuthate",{"label":35,"type":30,"description":36,"interventionNames":37},"vonoprazan-amoxicillin dual therapy","vonoprazan 20mg twice a day + amoxicillin 750mg，Four times a day",[38],"Drug: vonoprazan, amoxicillin",{"label":40,"type":30,"description":41,"interventionNames":42},"proton pump inhibitor-based standard triple therapy","rabeprazole 20mg twice a day + amoxicillin 1gm twice a day + clarithromycin 500mg twice a day",[43],"Drug: rabeprazole, amoxicillin, clarithromycin",[45,49,52],{"type":46,"name":47,"description":29,"armGroupLabels":48,"otherNames":18},"DRUG","vonoprazan, amoxicillin, tripotassium dicitrate bismuthate",[29],{"type":46,"name":50,"description":35,"armGroupLabels":51,"otherNames":18},"vonoprazan, amoxicillin",[35],{"type":46,"name":53,"description":40,"armGroupLabels":54,"otherNames":18},"rabeprazole, amoxicillin, clarithromycin",[40],[56],{"name":57,"role":58,"phone":59,"phoneExt":60,"email":61},"Deng-Chyang Wu, MD, PHD","CONTACT","88673121101","7451","dechwu@yahoo.com",[63],{"facility":64,"status":65,"city":66,"state":18,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Kaohsiung Medical University Hospital","RECRUITING","Kaohsiung City","807","Taiwan","TW",{"type":71,"coordinates":72},"Point",[73,74],120.31333,22.61626,{"lat":74,"lon":73},[77],{"name":78,"role":58,"phone":79,"phoneExt":60,"email":61},"Deng-Chyang Wu, MD,PHD","886-7-3121101",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","DENG-CHYANG WU","clinical professor","100542947",false,"NCT06349486","Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication","Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy in the First-line Anti-H. Pylori Treatment","Inclusion Criteria:\n\n(1) At least 18 years old. (2) Subjects infected with Helicobacter pylori.\n\nExclusion Criteria:\n\n1. Those who have ever received Helicobacter pylori sterilization treatment.\n2. Those who are allergic to the drugs used in this research.\n3. Those who have had stomach surgery.\n4. Those with severe liver cirrhosis or uremia or malignant tumors.\n5. Women who are pregnant or breastfeeding.","ALL","18 Years",{"count":93,"type":94},390,"ESTIMATED","INTERVENTIONAL",[97],"NA","1. Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.\n2. To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.",[100],"Helicobacter Pylori Eradication","2026-01-13",{"date":103,"type":104},"2026-01-15","ACTUAL",{"date":106,"type":104},"2023-11-28",{"date":108,"type":94},"2026-12-31",{"name":5,"class":6},1]