[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615538":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":54,"locations":60,"responsibleParty":73,"collaborators":33,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":33,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":33,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":63,"whyStopped":33,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Tanta University","OTHER",[8,16,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Vonoprazan group","ACTIVE_COMPARATOR","22 patients will receive vonoprazan (20 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily for 2 weeks",[13,14,15],"Drug: Vonoparazan","Drug: Amoxicillin","Drug: Clarithromycin 500 mg",{"label":17,"type":10,"description":18,"interventionNames":19},"Probiotic group","22 patients will receive proton pump inhibitor-based triple therapy omeprazole \u002Fpantoprazole (40 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily with lactobacillus acidophilus (5 billion CFU) three times daily for 2 weeks.",[20,14,15,21],"Drug: Probiotic","Drug: Proton Pump Inhibitor (PPI) Therapy",{"label":23,"type":10,"description":24,"interventionNames":25},"Vitamin D group","22 patients will receive proton pump inhibitor-based triple therapy omeprazole \u002Fpantoprazole (40mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily with vitamin D (2000 I.U.) once daily for 2 weeks.",[26,14,15,21],"Drug: Vitamin D",[28,34,38,42,46,50],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Vonoparazan","Vonoprazan: Potassium competitive acid blocker",[9],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Vitamin D","MIcronutrient",[23],{"type":29,"name":39,"description":40,"armGroupLabels":41,"otherNames":33},"Probiotic","Lactobacillus acidophilus",[17],{"type":29,"name":43,"description":44,"armGroupLabels":45,"otherNames":33},"Amoxicillin","Amoxicillin is penicillin-type antibiotic used to treat a wide range of bacterial infections.",[17,23,9],{"type":29,"name":47,"description":48,"armGroupLabels":49,"otherNames":33},"Clarithromycin 500 mg","Clarithromycin is a prescription macrolide antibiotic used to treat a variety of bacterial infections",[17,23,9],{"type":29,"name":51,"description":52,"armGroupLabels":53,"otherNames":33},"Proton Pump Inhibitor (PPI) Therapy","Proton Pump Inhibitors (PPIs) are powerful medications that significantly reduce stomach acid production by blocking the H+\u002FK+ ATPase enzymes (proton pumps) in the stomach lining,",[17,23],[55],{"name":56,"role":57,"phone":58,"phoneExt":33,"email":59},"Hagar Khaled Dewidar, Msc in Clinical Pharmacy","CONTACT","+201014679670","hagar.dewidar@pharm.tanta.edu.eg",[61],{"facility":62,"status":63,"city":64,"state":33,"zip":33,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":33},"Tanta university hospital","RECRUITING","Tanta","Egypt","EG",{"type":68,"coordinates":69},"Point",[70,71],31.00192,30.78847,{"lat":71,"lon":70},{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Hagar Khaled Bassuony Dewidar","Assistant Lecturer of Clinical Pharmacy","100615538","phase-2-vonoprazan-vs-proton-pump-inhibitor-with-vitamin-d-or-probiotics-based-triple-therapy-for-eradication-of-helicobacter-pylori-infection-100615538",false,"NCT07293910","Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection","Safety and Efficacy of Vonoprazan vs Proton Pump Inhibitor With Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection","Inclusion Criteria:\n\n* Both male and female patients. • Patients ≥ 18 and \\\u003C80 years old.\n\nPatients with confirmed diagnosis of H. pylori infection using either stool antigen test, urea breath test or endoscopy.\n\nExclusion Criteria:\n\n* Pregnant or lactating patients. • Patients with inflammatory diseases. • Patients sensitive to any of the regimens' components. • Patients who had received a previous eradication therapy, recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month.\n\nPatients with previous incidents of gastric or duodenal bleeding, gastric surgery or gastric malignancy.\n\n• Patients with active liver disease.\n\n• Patients with renal impairment.\n\n• Concurrent use of liver enzyme inducers, inhibitors or drugs with high plasma protein binding.","ALL","18 Years","80 Years",{"count":88,"type":89},66,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","Helicobacter pylori is a Gram-negative, spiral-shaped bacterium that infects up to 50% of the world's population, residing in the gastric mucosa and using the mucus layer for protection from the stomach's high acidity. Its clinical significance is profound: it is classified as a Group 1 carcinogen by the World Health Organization and is a primary cause of chronic gastritis, peptic ulcers, gastric lymphoma, and gastric carcinoma. The current first-line treatment, a PPI-based triple therapy (PPI + clarithromycin + amoxicillin), is experiencing a decline in efficacy (cure rates of 50-70%) due to widespread antibiotic resistance and compliance issues. To overcome this, newer agents like Vonoprazan Fumarate, a Potassium-Competitive Acid Blocker (P-CAB), are being adopted. Vonoprazan works by reversibly inhibiting the H+, K+ ATPase pump achieving stronger and longer-lasting acid suppression than PPIs because it does not require acid activation and is more stable in an acidic environment. In addition to pharmacological treatment, adjunctive therapies show promise. Vitamin D, acting through Vitamin D Receptor (VDR), assists in eradication by upregulating antimicrobial proteins like beta-defensin and cathelicidin, and its metabolite can cause bacterial cell lysis. Probiotics (primarily Lactobacillus and Bifidobacterium strains) enhance eradication rates by restricting bacterial growth, inhibiting adhesion, and exerting an anti-inflammatory effect through decreased interleukin-8 production. Finally, helicobacter pylori infection is marked by significant inflammation and oxidative stress. The bacterial protein TIP alpha induces high levels of the pro-inflammatory cytokine TNF alpha. Furthermore, the infection increases free radical production, leading to oxidative stress reflected by high levels of malondialdehyde. Systemic inflammation is also evident as helicobacter pylori infection is associated with significantly elevated serum C-reactive protein levels, which decrease upon successful eradication.\n\nAim of the work:\n\nThis study aims at evaluating the safety and efficacy of Vonoprazan vs Proton Pump Inhibitor with Vitamin D or Probiotics Based Triple Therapy for Eradication of Helicobacter Pylori Infection.",[95,96,97,98],"HELICOBACTER PYLORI INFECTIONS","Helicobacter Infection","Helicobacter Pylori Gastrointestinal Tract Infection","Helicobacter Pylori Infected Patients",[100,101,35,102,103,104,105,106],"Helicobacter Pylori","Vonoprazan","Probiotics","Lactobacillus","C-reactive protein","Tumor necrosis factor alpha","Malondialdehyde","2026-02-11",{"date":109,"type":110},"2026-02-13","ACTUAL",{"date":112,"type":89},"2026-02-15",{"date":114,"type":89},"2026-12-20",{"name":5,"class":6},1]