7-day High-Dose Vonoprazan-amoxicillin Dual Therapy Versus 14-day Vonoprazan-amoxicillin Dual Therapy for H. Pylori

Efficacy and Safety of Short-Term, High-Dose Vonoprazan-Based Dual Therapy Versus Standard-Dose Vonoprazan-Based Dual Therapy for Helicobacter Pylori Eradication: A Multicenter, Open-Label, Randomized Controlled Trial

Helicobacter pylori infection is a prevalent global gastrointestinal condition linked to chronic gastritis, peptic ulcer disease, and gastric cancer. Potent and sustained acid suppression improves eradication efficacy. Vonoprazan, a potassium-competitive acid blocker, provides rapid and stable acid inhibition and has become an important component of dual therapy with amoxicillin. However, the optimal dosing strategy and treatment duration for vonoprazan-based dual therapy are not yet fully established.

This multicenter, open-label, randomized controlled trial compares the efficacy and safety of a short-term, high-dose vonoprazan-based dual therapy (20 mg three times daily for 7 days) with a standard-dose regimen (20 mg twice daily for 14 days), both combined with amoxicillin, for first-line H. pylori eradication. Adult participants with confirmed H. pylori infection will be randomized 1:1 to the two treatment groups. The primary outcome is the eradication rate of H. pylori at 6 weeks after completion of therapy. Secondary outcomes include safety assessments and medication adherence. This study will provide evidence on whether a higher dose and shorter treatment course can achieve similar eradication rates with acceptable safety and tolerability compared to the standard regimen.

Study Overview

• Status: Not yet recruiting
• Conditions: Helicobacter
• Intervention / Treatment: Drug: 7-day high-dose vonoprazan-amoxicillin dual therapy group; Drug: 14-day vonoprazan-amoxicillin dual therapy group

• Study Type: Interventional
• Enrollment (Estimated): 290
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Xinjiang
    • Kashgar, Xinjiang, China, 844000
      • Kashi Prefecture Hospital of Traditional Chinese Medicine
      • Contact: Yueyue Li; Phone Number: +86 18560089751; Email: lyynqj@126.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age 18-70 years, no gender restrictions;
• Patients with H. pylori infection confirmed by 13C/14C-urea breath test ;
• No prior history of H. pylori eradication therapy;

Exclusion Criteria:

• Patients allergic to study medications (vonoprazan fumarate, amoxicillin);
• Patients with active qastrointestinal bleeding,;
• Patients undergone or scheduled to undergo surgery within 1 month prior to randomization or during the study period that may affect gastric acid secretion (e.g., gastric surgery, vagotomy, or craniotomy);
• Patients underlying severe medical conditions deemed by the investigator to potentially confound study results or compromise subject safety, such as: hepatic impairment (ALT or AST > 1.5 times the upper limit of normal); renal impairment (Cr ≥ 2.0 mg/dL or eGFR < 50 mL/min/1.73 m²); immunosuppression; malignancy; severe central nervous system, cardiovascular, or respiratory disease;
• Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitors within 2 weeks;
• Patients with behaviors potentially increasing disease risk: history of chronic substance abuse or alcohol dependence within 12 months prior to screening;
• Patients planning pregnancy, currently pregnant, breastfeeding, or unwilling to use contraception during the trial period;
• Patients 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: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 7-day high-dose vonoprazan-amoxicillin dual therapy group	Drug: 7-day high-dose vonoprazan-amoxicillin dual therapy group; Patients in the 7-day high-dose vonoprazan-amoxicillin dual therapy group received vonoprazan fumarate tablets 20 mg three times daily, administered 30 minutes before meals, and amoxicillin 1,000 mg three times daily, taken after meals. Both medications were administered orally for 7 consecutive days.
Experimental: 14-day vonoprazan-amoxicillin dual therapy group	Drug: 14-day vonoprazan-amoxicillin dual therapy group; Patients in the 14-day vonoprazan-amoxicillin dual therapy group received vonoprazan fumarate tablets 20 mg twice daily, administered 30 minutes before meals, and amoxicillin 1,000 mg three times daily, taken after meals. Both medications were administered orally for 14 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eradication rate	6 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
incidence of adverse events	immediately after treatment

Collaborators and Investigators

• Sponsor: Yueyue Li
• Collaborators: Qilu Hospital of Shandong University; Shandong University of Traditional Chinese Medicine; Zaozhuang Municipal Hospital; Guanxian People's Hospital; Yantai Zhifu Hospital; Qilu Hospital of Shandong University, Dezhou Branch; Kashi Prefecture Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: dual therapy; short term
• Other Study ID Numbers: 202510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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