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

NCT07537634 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Helicobacter Pylori Infection
  • Dyspepsia
  • Peptic Ulcer Disease
  • Helicobacter Pylori
  • H Pylori

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

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • Syeda Mubashsharah Mahfuz, MBBS · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2026-08-14
Completion
2026-08-14

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07537634 on ClinicalTrials.gov