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Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication

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

About this trial

1. Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection. 2. To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Those who have ever received Helicobacter pylori sterilization treatment.

Those who are allergic to the drugs used in this research.

Those who have had stomach surgery.

Those with severe liver cirrhosis or uremia or malignant tumors.

Trial design

Design model

Parallel

Treatments tested in this trial

  • vonoprazan, amoxicillin, tripotassium dicitrate bismuthate

    Drug

    bismuth-amoxicillin-vonoprazan triple therapy

  • vonoprazan, amoxicillin

    Drug

    vonoprazan-amoxicillin dual therapy

  • rabeprazole, amoxicillin, clarithromycin

    Drug

    proton pump inhibitor-based standard triple therapy

Treatment groups

390 Participants
are divided into 3 treatment groups
Group A: bismuth-amoxicillin-vonoprazan triple therapyActive comparator 1 intervention
Group B: vonoprazan-amoxicillin dual therapyActive comparator 1 intervention
Group C: proton pump inhibitor-based standard triple therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

the eradication rate of Helicobacter pylori

evalute eradication outcome by 13C urea breath test

Time frame
8 week after finishing study drugs

Secondary outcomes

1

genotype analysis

CYP3A4, CYP2C19 and IL-1B -511 genotypes

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kaohsiung Medical University

Lead sponsor

Source ClinicalTrials.gov
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