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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07358130

Enrollment

552

Registered

2026-01-22

Start date

2025-10-21

Completion date

2027-12-31

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori eradication

Brief summary

(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.

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.

Interventions

DRUGvonoprazan, tripotassium dicitrate bismuthate, amoxicilline

bismuth-amoxicillin-vonoprazan triple therapy

DRUGrabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole

bismuth-based quadruple therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

bismuth-based quadruple therapy

Intervention model description

bismuth-amoxicillin-vonoprazan triple therapy

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Taiwan

Contacts

CONTACTDeng-Chyang Wu, MD, PHD

dechwu@yahoo.com88673121101

PRINCIPAL_INVESTIGATORDeng-Chyang Wu, MD, PHD

Kaohsiung Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026