Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication (NCT07537634) | Clinical Trial Compass
RecruitingPhase 4
Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication
Bangladesh80 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. Dyspeptic patients with positive for both rapid urease test and stool antigen test
✓. Patients giving written informed consent
Exclusion criteria
✕. Treatment with a proton pump inhibitor, H2-receptor antagonist within the last 2 weeks, prior to the study
✕. Treatment with antibiotics or bismuth preparation within 4 weeks prior to the study
✕. Previous H. pylori eradication therapy
✕. Gastric or duodenal ulcer with current or recent bleeding on endoscopy
✕. Significant upper or lower gastrointestinal bleeding within 4 weeks
✕. Patients with regular intake of NSAIDs or steroids
✕. Surgery that might affect gastric acid secretion e.g., upper GI resection or vagotomy
What they're measuring
1
H. pylori Eradication Rate
Timeframe: 4 weeks after completion of 14-day therapy
Trial details
NCT IDNCT07537634
SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh