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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaohsiung Medical University

About this trial

(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 criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with Helicobacter pylori infection

Disqualifiers

Subjects with known hypersensitivity to the study drug.

Subjects with a history of gastric surgery.

Subjects with severe liver cirrhosis or uremia.

Subjects with a history of malignancy within the past five years.

Trial design

Design model

Parallel

Treatments tested in this trial

  • vonoprazan, tripotassium dicitrate bismuthate, amoxicilline

    Drug

    bismuth-amoxicillin-vonoprazan triple therapy

  • rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole

    Drug

    bismuth-based quadruple therapy

Treatment groups

552 Participants
are divided into 2 treatment groups
Group A: bismuth-amoxicillin-vonoprazan triple therapyActive comparator 1 intervention
Group B: bismuth-based quadruple therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The rate of Helicobacter pylori eradication

evaluate eradication by 13C urea breath test

Time frame
6 weeks after finishing study drugs
2

Evaluation of the safety of Helicobacter pylori eradication therapy

Drug-related adverse effects assessed by a standardized questionnaire

Time frame
14 days

Secondary outcomes

1

genotype analysis

Genotype analysis (CYP3A4, CYP2C19, and IL-1B -511) will be performed using a blood sample collected once at study entry.

Time frame
baseline

Other outcomes

Sponsors and contacts

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Kaohsiung Medical University

Lead sponsor

Kaohsiung Veterans General Hospital.

Collaborator