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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
vonoprazan, tripotassium dicitrate bismuthate, amoxicilline
Drugbismuth-amoxicillin-vonoprazan triple therapy
rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole
Drugbismuth-based quadruple therapy
Treatment groups
Trial outcomes
Primary outcomes
The rate of Helicobacter pylori eradication
evaluate eradication by 13C urea breath test
Evaluation of the safety of Helicobacter pylori eradication therapy
Drug-related adverse effects assessed by a standardized questionnaire
Secondary outcomes
genotype analysis
Genotype analysis (CYP3A4, CYP2C19, and IL-1B -511) will be performed using a blood sample collected once at study entry.
Sponsors and contacts
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Kaohsiung Medical University
Lead sponsor
Kaohsiung Veterans General Hospital.
Collaborator