Status:
NOT_YET_RECRUITING
Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial
Lead Sponsor:
Yanqing Li
Collaborating Sponsors:
Longkou People's Hospital
Qingdao Jimo People's Hospital
Conditions:
HELICOBACTER PYLORI INFECTIONS
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Aged 18-70 years, male or female
- Current Helicobacter pylori infection (positive 13C-urea breath test)
- No prior Helicobacter pylori eradication therapy
Exclusion
- Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours
- Active gastrointestinal bleeding
- History of upper gastrointestinal surgery
- History of drug hypersensitivity
- Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks
- Pregnant or lactating women
- Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use
- Individuals unable or unwilling to provide informed consent
Key Trial Info
Start Date :
September 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT07179159
Start Date
September 9 2025
End Date
December 31 2026
Last Update
September 17 2025
Active Locations (1)
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1
Qilu Hospital of Shandong University
Jinan, China