NCT07358130

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
552

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Oct 2025Dec 2027

Study Start

First participant enrolled

October 21, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 22, 2026

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

December 12, 2025

Last Update Submit

January 13, 2026

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori eradication

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • genotype analysis

    baseline

Study Arms (2)

bismuth-amoxicillin-vonoprazan triple therapy

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

vonoprazan, tripotassium dicitrate bismuthate, amoxicillineDRUG

bismuth-amoxicillin-vonoprazan triple therapy

Also known as: triple therapy
bismuth-based quadruple therapy
rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazoleDRUG

bismuth-based quadruple therapy

Also known as: quadruple therapy
bismuth-amoxicillin-vonoprazan triple therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with Helicobacter pylori infection

You may not qualify if:

  • 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.
  • Pregnant or breastfeeding women.
  • Subjects currently receiving treatment with atazanavir sulfate or rilpivirine hydrochloride.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamineAmoxicillinRabeprazoleTetracyclineMetronidazole

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesPyridinesHeterocyclic Compounds, 1-RingBenzimidazolesTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsNitroimidazolesNitro CompoundsImidazolesAzoles

Study Officials

  • Deng-Chyang Wu, MD, PHD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deng-Chyang Wu, MD, PHD

CONTACT

88673121101dechwu@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
bismuth-based quadruple therapy
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: bismuth-amoxicillin-vonoprazan triple therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Physician

Study Record Dates

First Submitted

December 12, 2025

First Posted

January 22, 2026

Study Start

October 21, 2025

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 22, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)