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Recruiting Not applicable

Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy

NCT07358130 · tracked via the Priya Life Science Taiwan tracker
Phase
Not applicable
Started
2025-10-21
Last updated
2026-01-22

Condition(s) studied

Helicobacter Pylori Infection

Investigational drug(s) / intervention(s)

vonoprazan, tripotassium dicitrate bismuthate, amoxicillinerabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole

vonoprazan, tripotassium dicitrate bismuthate, amoxicilline: bismuth-amoxicillin-vonoprazan triple therapy

rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole: bismuth-based quadruple therapy

Study summary

(1) To compare the efficacy and safety of a 14-day bismuth-amoxicillin-vonoprazan triple therapy versus a 14-day bismuth-based quadruple therapy as first-line treatments for H. pylori infection, and (2) To investigate the influence of H. pylori antibiotic resistance, along with host CYP3A4, CYP2C19, and IL-1B -511 genotypes, on the eradication efficacy of H. pylori therapies.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Subjects with Helicobacter pylori infection Exclusion Criteria: 1. Subjects with known hypersensitivity to the study drug. 2. Subjects with a history of gastric surgery. 3. Subjects with severe liver cirrhosis or uremia. 4. Subjects with a history of malignancy within the past five years. 5. Pregnant or breastfeeding women. 6. Subjects currently receiving treatment with atazanavir sulfate or rilpivirine hydrochloride.

Primary outcome measure(s)

  • The rate of Helicobacter pylori eradication — 6 weeks after finishing study drugs
    evaluate eradication by 13C urea breath test
  • Evaluation of the safety of Helicobacter pylori eradication therapy — 14 days
    Drug-related adverse effects assessed by a standardized questionnaire

Trial sites (1)

FacilityCityRegionStatus
Kaohsiung Medical University Hospital Kaohsiung City Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07358130 on ClinicalTrials.gov ↗ ← All trials in Taiwan