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RECRUITING
NCT07537634
PHASE4

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

Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

View on ClinicalTrials.gov

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.

Official title: Comparison Between Vonoprazan-Based Triple Therapy and Esomeprazole-Based Triple Therapy for Eradication of Helicobacter Pylori Infection: An Open-Label Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-04-15

Completion Date

2026-08-14

Last Updated

2026-04-22

Healthy Volunteers

No

Interventions

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

DRUG

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

Locations (2)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh