RecruitingPhase 4NCT07537634

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


Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Enrollment

80 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Esomeprazole-based triple therapy (EAL regimen) and a drug called vonoprazan-based triple therapy (VAL regimen) for people with dyspepsia, h-pylori, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGvonoprazan-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

DRUGEsomeprazole-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


Locations(2)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

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NCT07537634


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