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

Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy in the First-line Anti-H. Pylori Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Eradication
• Intervention / Treatment: Drug: vonoprazan, amoxicillin, tripotassium dicitrate bismuthate; Drug: vonoprazan, amoxicillin; Drug: rabeprazole, amoxicillin, clarithromycin

Detailed Description

For this multi-center, randomized, open-label, superiority trial, we will recruit 780 adult patients with H. pylori infection from ten medical centers or regional hospitals in Taiwan. Using a computer generated randomized sequence, we randomly allocate patients (1:1:1; block size of six) to either 14-day bismuth-amoxicillin-vonoprazan triple therapy, 14-day vonoprazan dual therapy, or 14-day rabeprazole-triple therapy. Patients are asked to return at the second week to assess drug adherence and adverse events. Post-treatment H. pylori status is assessed by 13C-urea breath test at week 6. Participants with failure of H. pylori eradication will randomly receive either 14-day vonoprazan-based or 14-day esomeprazole-based bismuth quadruple therapy. Finally, the rates of eradication and adverse events will be compared between groups by chi-square test. Additionally, the effects of antibiotic resistances of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of above first-line and second-line anti-H. pylori treatments are assessed by multivariate analysis.

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DENG-CHYANG WU, MD, PHD; Phone Number: 7451 88673121101; Email: dechwu@yahoo.com

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Recruiting
    • Kaohsiung Medical University Hospital
    • Contact: Deng-Chyang Wu, MD,PHD; Phone Number: 7451 886-7-3121101; Email: dechwu@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

(1) At least 18 years old. (2) Subjects infected with Helicobacter pylori.

Exclusion Criteria:

1. Those who have ever received Helicobacter pylori sterilization treatment.
2. Those who are allergic to the drugs used in this research.
3. Those who have had stomach surgery.
4. Those with severe liver cirrhosis or uremia or malignant tumors.
5. Women who are pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bismuth-amoxicillin-vonoprazan triple therapy; vonoprazan 20mg twice a day + amoxicillin 750mg four times a day + tripotassium dicitrate bismuthate 300mg four times a day	Drug: vonoprazan, amoxicillin, tripotassium dicitrate bismuthate; bismuth-amoxicillin-vonoprazan triple therapy
Active Comparator: vonoprazan-amoxicillin dual therapy; vonoprazan 20mg twice a day + amoxicillin 750mg，Four times a day	Drug: vonoprazan, amoxicillin; vonoprazan-amoxicillin dual therapy
Active Comparator: proton pump inhibitor-based standard triple therapy; rabeprazole 20mg twice a day + amoxicillin 1gm twice a day + clarithromycin 500mg twice a day	Drug: rabeprazole, amoxicillin, clarithromycin; proton pump inhibitor-based standard triple therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the eradication rate of Helicobacter pylori	evalute eradication outcome by 13C urea breath test	8 week after finishing study drugs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
genotype analysis	CYP3A4, CYP2C19 and IL-1B -511 genotypes	1 day

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; Macrolides; Lactones; Penicillin G; beta-Lactams; Lactams; Erythromycin; Polyketides; Ampicillin; Penicillins; Amoxicillin; Clarithromycin; Rabeprazole; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
• Other Study ID Numbers: KMUHIRB-F(II)-20230179

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No