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RECRUITINGNA

Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial

NCT07179159•Yanqing Li

Summary

This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18-70 years, male or female
•2. Current Helicobacter pylori infection (positive 13C-urea breath test)
•3. No prior Helicobacter pylori eradication therapy

Exclusion Criteria

•1. Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours
•2. Active gastrointestinal bleeding
•3. History of upper gastrointestinal surgery
•4. History of drug hypersensitivity
•5. Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks
•6. Pregnant or lactating women
•7. Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use
•8. Individuals unable or unwilling to provide informed consent

Locations (2)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Qilu Hospital of Shandong University

Jinan, China

Key Dates

Start Date

September 9, 2025

Primary Completion Date

August 31, 2026

Completion Date

December 31, 2026

Last Updated

March 10, 2026

Enrollment

372

ESTIMATED participants

Conditions

HELICOBACTER PYLORI INFECTIONS

Interventions

14-day vonoprazan-amoxicillin dual therapy

DRUG

14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy

DRUG

14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy

DRUG

Contacts

Yueyue Li

CONTACT

+8618560089751 lyynqj@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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