[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634280":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":29,"armGroups":37,"interventions":50,"overallOfficials":60,"centralContacts":64,"locations":73,"responsibleParty":98,"collaborators":29,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":29,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":29,"enrollmentInfo":110,"targetDuration":29,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":123,"overallStatus":90,"whyStopped":29,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"H. pylori Eradication Rate","Proportion of participants with confirmed eradication of Helicobacter pylori, defined as a negative stool antigen test performed 4 weeks after completion of therapy.","4 weeks after completion of 14-day therapy",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"Endoscopic Mucosal Healing rate","Proportion of participants with healed gastric or duodenal mucosal lesions assessed by repeat upper gastrointestinal endoscopy 4 weeks after completion of therapy.","4 weeks after completion of therapy.",{"measure":19,"description":20,"timeFrame":12},"Change in dyspeptic symptom severity score","Dyspeptic symptoms were assessed using an 8-item, 5-point Likert scale at baseline and 4 weeks after completion of therapy. Each item was scored from 1 (no symptom) to 5 (very severe), yielding a total score ranging from 8 to 40. Lower scores indicated fewer symptoms. Improvement was defined as a reduction in total symptom score from baseline",{"measure":22,"description":23,"timeFrame":24},"Adverse Events","Incidence and type of treatment-related adverse events reported during and up to 4 weeks after completion of therapy.","During therapy and up to 4 weeks after therapy completion",{"measure":26,"description":27,"timeFrame":28},"Compliance to Therapy","Proportion of participants who complete the prescribed 14-day therapy as per protocol.","End of therapy (14 days)",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE","This open-label randomized controlled trial will be conducted in the outpatient Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University (BMU), following institutional ethical approval. Consecutive adult patients presenting with dyspepsia or symptoms suggestive of peptic ulcer disease will be initially evaluated for enrollment. Eligible patients will undergo screening for Helicobacter pylori infection using a stool antigen test. Fresh stool samples will be collected in sterile containers and analyzed using a one-step chromatographic immunoassay for H. pylori antigen detection.\n\nPatients with positive stool antigen results will undergo upper gastrointestinal endoscopy after assessment of procedural fitness and obtaining written informed consent. Endoscopy will be performed by experienced gastroenterologists using standard endoscopic equipment. During endoscopy, mucosal abnormalities including gastritis, erosions, duodenal ulcers, and gastric ulcers will be documented in a structured data collection form. Biopsy specimens from the gastric antrum and corpus will be obtained for rapid urease testing. Additional biopsies will be taken from suspicious lesions when clinically indicated.\n\nOnly patients with positive results on both stool antigen testing and rapid urease testing will be enrolled in the study. Enrolled participants will be randomly assigned in a 1:1 ratio into two treatment groups. One group will receive vonoprazan-based levofloxacin-containing triple therapy, and the other group will receive esomeprazole-based levofloxacin-containing triple therapy. Both treatment regimens will be administered for 14 days. Participants will be instructed regarding medication timing and adherence.\n\nAll study medications will be supplied from the same pharmaceutical source and stored under recommended conditions. Participants will be followed at the end of therapy to assess treatment compliance and document any adverse events. A subsequent follow-up visit will be scheduled 4 weeks after completion of therapy, during which repeat stool antigen testing will be performed to assess H. pylori eradication. Participants with mucosal lesions identified at baseline endoscopy will undergo repeat upper gastrointestinal endoscopy to evaluate mucosal healing.\n\nAll study findings, including eradication outcomes, treatment adherence, adverse effects, and endoscopic healing status where applicable, will be systematically documented and analyzed upon completion of follow-up.\n\nStatistical analysis:\n\nThe following steps will be used to analyze the collected data:\n\n* The entered data will be checked, verified and analyzed by IBM® SPSS® Statistics version 27 (Statistical Program for Social Science) software.\n* The data will be presented in tables, figures and diagrammatical form.\n* Appropriate statistical test will be applied for data analysis. Numeric data (e.g. age, Likert scale score for dyspepsia) will be expressed as mean ± standard deviation and median (range), qualitative data (e.g. sex, stool antigen test, endoscopy of upper GIT) will be expressed as frequency and percentage.\n* Baseline characteristics of the study patients and outcomes will be evaluated using student's t-test, Chi-square test or Fisher's exact test, as appropriate.\n* Factors influencing the efficacy of the eradication therapy were assessed by univariate \\& multivariate analysis\n* A P-value less than 0.05 will be considered as significant at a 95% confidence interval (95% CI).",[38,44],{"label":39,"type":40,"description":41,"interventionNames":42},"Vonoprazan-based triple therapy (VAL)","EXPERIMENTAL","Participants in this arms will receive vonoprazan based levofloxacin containing triple therapy for 14 days",[43],"Drug: vonoprazan-based triple therapy (VAL regimen)",{"label":45,"type":46,"description":47,"interventionNames":48},"Esomeprazole-based triple therapy (EAL)","ACTIVE_COMPARATOR","Participants in this arms will receive esomeprazole based levofloxacin containing triple therapy for 14 days",[49],"Drug: Esomeprazole-based triple therapy (EAL regimen)",[51,56],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":29},"DRUG","vonoprazan-based triple therapy (VAL regimen)","vonoprazan 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days",[39],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":29},"Esomeprazole-based triple therapy (EAL regimen)","Esomeprazole 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days",[45],[61],{"name":62,"affiliation":5,"role":63},"Syeda Mubashsharah Mahfuz, MBBS","PRINCIPAL_INVESTIGATOR",[65,69],{"name":62,"role":66,"phone":67,"phoneExt":29,"email":68},"CONTACT","+8801756395139","mubashsharah68dmc@gmail.com",{"name":70,"role":66,"phone":71,"phoneExt":29,"email":72},"Md. Ahid Iqbal Khokan, MBBS, MD","+8801722787487","ahidiqbaldmc65@gmail.com",[74,89],{"facility":75,"status":76,"city":77,"state":29,"zip":29,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Bangabandhu Sheikh Mujib Medical University","NOT_YET_RECRUITING","Dhaka","Bangladesh","BD",{"type":81,"coordinates":82},"Point",[83,84],90.40744,23.7104,{"lat":84,"lon":83},[87,88],{"name":62,"role":66,"phone":67,"phoneExt":29,"email":68},{"name":70,"role":66,"phone":71,"phoneExt":29,"email":72},{"facility":75,"status":90,"city":77,"state":29,"zip":29,"country":78,"countryCode":79,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"RECRUITING",{"type":81,"coordinates":92},[83,84],{"lat":84,"lon":83},[95,96,97],{"name":62,"role":66,"phone":67,"phoneExt":29,"email":68},{"name":70,"role":66,"phone":71,"phoneExt":29,"email":72},{"name":62,"role":63,"phone":29,"phoneExt":29,"email":29},{"type":63,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Syeda Mubashsharah Mahfuz","Medical Officer (Resident)","100634280","phase-4-vonoprazan-based-versus-esomeprazole-based-triple-therapy-for-helicobacter-pylori-eradication-100634280",false,"NCT07537634","Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication","Comparison Between Vonoprazan-Based Triple Therapy and Esomeprazole-Based Triple Therapy for Eradication of Helicobacter Pylori Infection: An Open-Label Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Dyspeptic patients with positive for both rapid urease test and stool antigen test\n3. Patients giving written informed consent\n\nExclusion Criteria:\n\n1. Treatment with a proton pump inhibitor, H2-receptor antagonist within the last 2 weeks, prior to the study\n2. Treatment with antibiotics or bismuth preparation within 4 weeks prior to the study\n3. Previous H. pylori eradication therapy\n4. Gastric or duodenal ulcer with current or recent bleeding on endoscopy\n5. Significant upper or lower gastrointestinal bleeding within 4 weeks\n6. Patients with regular intake of NSAIDs or steroids\n7. Surgery that might affect gastric acid secretion e.g., upper GI resection or vagotomy\n8. Known case of malignancy, including MALToma\n9. Advanced co-morbidities (e.g., CLD, CKD, cardio-respiratory failure, known thyroid disease)\n10. Chronic alcohol abuse, chronic illegal drug use, or drug addiction within the past 12 months\n11. Pregnant, lactating woman or intend to become pregnant within the study period\n12. History of hypersensitivity to vonoprazan, PPIs, amoxicillin, and\u002For levofloxacin\n13. On colchicine\n14. Subjects with abnormal laboratory test at the start of the screening period:\n\nS. creatinine \\> 2 mg\u002Fdl SGPT \\> 2 x Upper limit of normal","ALL","18 Years",{"count":111,"type":112},80,"ESTIMATED","INTERVENTIONAL",[115],"PHASE4","The goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia.\n\nThe main questions it aims to answer are whether vonoprazan-based triple therapy achieves a higher eradication rate of H. pylori, whether it provides greater improvement in dyspeptic symptoms, and what adverse effects are associated with each regimen.\n\nResearchers will compare the two treatment regimens to determine which is more effective for H. pylori eradication.\n\nParticipants with confirmed H. pylori infection will be randomly assigned to receive either vonoprazan-based or esomeprazole-based triple therapy for 14 days.\n\nFour weeks after completion of therapy, participants will undergo repeat stool antigen testing to assess eradication.\n\nDrug compliance, adverse effects, and dyspeptic symptom scores will be recorded during follow-up.\n\nParticipants with endoscopic mucosal lesions at baseline will undergo follow-up endoscopy for reassessment.",[118,119,120,121,122],"Helicobacter Pylori Infection","Dyspepsia","Peptic Ulcer Disease","Helicobacter Pylori","H Pylori",[124,125,126,127,128,129,119],"Helicobacter pylori","Helicobacter pylori eradication","Vonoprazan","Esomeprazole","Levofloxacin","Triple therapy","2026-04-18",{"date":132,"type":133},"2026-04-22","ACTUAL",{"date":135,"type":112},"2026-04-15",{"date":137,"type":112},"2026-08-14",{"name":5,"class":6},2]