Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT07179159

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

Led by Yanqing Li · Updated on 2026-04-15

372

Participants Needed

2

Research Sites

68 weeks

Total Duration

On this page

Sponsors

Y

Yanqing Li

Lead Sponsor

L

Longkou People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-70 years, male or female
  • Confirmed H. pylori infection by positive 13C-urea breath test plus at least one positive result from stool antigen test, rapid urease test, or gastric mucosal biopsy
  • No prior treatment to eradicate Helicobacter pylori
Not Eligible

You will not qualify if you...

  • Severe underlying conditions such as liver or kidney failure, or cancer
  • Active gastrointestinal bleeding
  • History of upper gastrointestinal surgery
  • History of drug allergies
  • Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing drugs within the past 2 weeks
  • Pregnant or breastfeeding women
  • Risk behaviors like alcohol abuse or illicit drug use
  • Unable or unwilling to give informed consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250012

Actively Recruiting

2

Qilu Hospital of Shandong University

Jinan, China

Not Yet Recruiting

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Research Team

Y

Yueyue Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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