Clinical Trial

Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication

Recruiting Phase 4
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Record status
This record was last updated April 22, 2026 (before its estimated August 14, 2026 completion). Its status may not reflect the trial's current state.
Summary
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. The 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. Researchers will compare the two treatment regimens to determine which is more effective for H. pylori eradication. Participants with confirmed H. pylori infection will be randomly assigned to receive either vonoprazan-based or esomeprazole-based triple therapy for 14 days. Four weeks after completion of therapy, participants will undergo repeat stool antigen testing to assess eradication. Drug compliance, adverse effects, and dyspeptic symptom scores will be recorded during follow-up. Participants with endoscopic mucosal lesions at baseline will undergo follow-up endoscopy for reassessment.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-23
Trial Details
NCT Number NCT07537634
Lead Sponsor Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Conditions Helicobacter Pylori Infection, Dyspepsia, Peptic Ulcer Disease, Helicobacter Pylori, H Pylori
Enrollment 80 participants
Start Date 2026-04-15
Primary Completion 2026-08-14 (estimated)
Study Completion 2026-08-14 (estimated)
Updated on ClinicalTrials.gov 2026-04-22