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

Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy in the First-line Anti-Helicobacter Pylori Treatment

(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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole; Drug: vonoprazan, tripotassium dicitrate bismuthate, amoxicilline

Detailed Description

This multicenter, randomized, open-label, trial will enroll 552 adult patients with H. pylori infection from 12 medical centers or regional hospitals in Taiwan. Using a computer-generated randomization sequence (1:1 allocation; block size of four), participants will be assigned to receive either the 14-day bismuth-amoxicillin-vonoprazan triple therapy or the 14-day bismuth-rabeprazole-tetracycline-metronidazole quadruple therapy. Follow-up at week 2 will assess treatment adherence and adverse events. H. pylori status will be evaluated at week 6 using the C13-urea breath test. Eradication and adverse event rates will be compared between groups using the chi-square test. The impact of H. pylori antibiotic resistance and host CYP3A4, CYP2C19, and IL-1B -511 genotypes on treatment efficacy will be analyzed using multivariate models.

• Study Type: Interventional
• Enrollment (Estimated): 552
• 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 88673121101; Email: dechwu@yahoo.com

Participation Criteria

Eligibility Criteria

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

Description

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.

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bismuth-amoxicillin-vonoprazan triple therapy; vonoprazan 20mg twice a day +tripotassium dicitrate bismuthate 300mg four times a day +amoxicilline 750mg four times a day	Drug: rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole; bismuth-based quadruple therapy; Other Names: quadruple therapy
Active Comparator: bismuth-based quadruple therapy; rabeprazole 20mg twice a day+ tripotassium dicitrate bismuthate 300mg four times a day+ tetracycline 500mg four times a day+ metronidazole 250mg four times a day	Drug: vonoprazan, tripotassium dicitrate bismuthate, amoxicilline; bismuth-amoxicillin-vonoprazan triple therapy; Other Names: triple therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
genotype analysis	Genotype analysis (CYP3A4, CYP2C19, and IL-1B -511) will be performed using a blood sample collected once at study entry.	baseline

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University
• Collaborators: Kaohsiung Veterans General Hospital.
• Investigators: Principal Investigator: Deng-Chyang Wu, MD, PHD, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Helicobacter pylori eradication
• 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; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Imidazoles; Amides; Naphthacenes; Tetracyclines; Penicillin G; beta-Lactams; Lactams; Nitroimidazoles; Nitro Compounds; Ampicillin; Penicillins; Metronidazole; Tetracycline; Amoxicillin; Rabeprazole; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
• Other Study ID Numbers: KMUHIRB-F(I)-20250254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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