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

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.

Study Overview

• Status: Recruiting
• Conditions: HELICOBACTER PYLORI INFECTIONS
• Intervention / Treatment: Drug: 14-day vonoprazan-amoxicillin dual therapy; Drug: 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy; Drug: 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy

• Study Type: Interventional
• Enrollment (Estimated): 372
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yueyue Li; Phone Number: +8618560089751; Email: lyynqj@126.com

Study Locations

• China
  • Jinan, China
    • Not yet recruiting
    • Qilu Hospital of Shandong University
    • Contact: Yueyue Li; Phone Number: +8618560089751; Email: lyynqj@126.com
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Yueyue Li; Phone Number: 18560089751; Email: lyynqj@126.com
      • Contact: Email: lyynqj@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18-70 years, male or female
2. Patients with H. pylori infection (positive 13C-urea breath test, together with at least one positive result from the following three tests: (a) stool H. pylori antigen test; (b) rapid urease test; (c) histopathological examination of gastric mucosal biopsy tissue)
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 14-day vonoprazan-amoxicillin dual therapy	Drug: 14-day vonoprazan-amoxicillin dual therapy; vonoprazan 20mg bid + amoxicillin 1000mg bid
Active Comparator: 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy	Drug: 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy; vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid
Active Comparator: 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy	Drug: 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy; vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
eradication rate	6 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events		immediately after a 2-week treatment
compliance	Satisfactory compliance was defined as taking medications with at least 80% of the prescribed dosage. The proportion of patients with satisfactory compliance was calculated among all patients.	immediately after a 2-week treatment

Collaborators and Investigators

• Sponsor: Yanqing Li
• Collaborators: Qilu Hospital of Shandong University; Shandong University of Traditional Chinese Medicine; Longkou People's Hospital; The 2nd People's Hospital of Dongying City; Zibo Maternal and Child Health Hospital; Dezhou Hospital Qilu Hospital of Shandong University; Qingdao Jimo People's Hospital; Yantai Zhifu Hospital; Guanxian County People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 30, 2025
• First Submitted That Met QC Criteria: September 10, 2025
• First Posted (Actual): September 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 202509

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No