[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"helicobacter\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:helicobacter":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100620013","7-day-high-dose-vonoprazan-amoxicillin-dual-therapy-versus-14-day-vonoprazan-amoxicillin-dual-therapy-for-h-pylori-100620013",false,"NCT07352098","7-day High-Dose Vonoprazan-amoxicillin Dual Therapy Versus 14-day Vonoprazan-amoxicillin Dual Therapy for H. Pylori","Efficacy and Safety of Short-Term, High-Dose Vonoprazan-Based Dual Therapy Versus Standard-Dose Vonoprazan-Based Dual Therapy for Helicobacter Pylori Eradication: A Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18-70 years, no gender restrictions;\n* Patients with H. pylori infection confirmed by 13C\u002F14C-urea breath test ;\n* No prior history of H. pylori eradication therapy;\n\nExclusion Criteria:\n\n* Patients allergic to study medications (vonoprazan fumarate, amoxicillin);\n* Patients with active qastrointestinal bleeding,;\n* Patients undergone or scheduled to undergo surgery within 1 month prior to randomization or during the study period that may affect gastric acid secretion (e.g., gastric surgery, vagotomy, or craniotomy);\n* Patients underlying severe medical conditions deemed by the investigator to potentially confound study results or compromise subject safety, such as: hepatic impairment (ALT or AST \\> 1.5 times the upper limit of normal); renal impairment (Cr ≥ 2.0 mg\u002FdL or eGFR \\\u003C 50 mL\u002Fmin\u002F1.73 m²); immunosuppression; malignancy; severe central nervous system, cardiovascular, or respiratory disease;\n* Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitors within 2 weeks;\n* Patients with behaviors potentially increasing disease risk: history of chronic substance abuse or alcohol dependence within 12 months prior to screening;\n* Patients planning pregnancy, currently pregnant, breastfeeding, or unwilling to use contraception during the trial period;\n* Patients unable or unwilling to provide informed consent.","ALL","18 Years","70 Years",{"count":20,"type":21},290,"ESTIMATED","INTERVENTIONAL",[24],"NA","Helicobacter pylori infection is a prevalent global gastrointestinal condition linked to chronic gastritis, peptic ulcer disease, and gastric cancer. Potent and sustained acid suppression improves eradication efficacy. Vonoprazan, a potassium-competitive acid blocker, provides rapid and stable acid inhibition and has become an important component of dual therapy with amoxicillin. However, the optimal dosing strategy and treatment duration for vonoprazan-based dual therapy are not yet fully established.\n\nThis multicenter, open-label, randomized controlled trial compares the efficacy and safety of a short-term, high-dose vonoprazan-based dual therapy (20 mg three times daily for 7 days) with a standard-dose regimen (20 mg twice daily for 14 days), both combined with amoxicillin, for first-line H. pylori eradication. Adult participants with confirmed H. pylori infection will be randomized 1:1 to the two treatment groups. The primary outcome is the eradication rate of H. pylori at 6 weeks after completion of therapy. Secondary outcomes include safety assessments and medication adherence. This study will provide evidence on whether a higher dose and shorter treatment course can achieve similar eradication rates with acceptable safety and tolerability compared to the standard regimen.",[27],"Helicobacter",[29,30],"dual therapy","short term","NOT_YET_RECRUITING","2026-01-11",{"date":34,"type":35},"2026-01-20","ACTUAL",{"date":37,"type":21},"2026-02-01",{"date":39,"type":21},"2028-02-01",{"name":41,"class":42},"Yueyue Li","OTHER"]