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

Summary

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.

Conditions

• Helicobacter

Interventions

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.

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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University

  collaborator OTHER

• Shandong University of Traditional Chinese Medicine

  collaborator OTHER

• Zaozhuang Municipal Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University, Dezhou Branch

  collaborator UNKNOWN

• Yantai Zhifu Hospital

  collaborator UNKNOWN

• Kashi Prefecture Hospital of Traditional Chinese Medicine

  collaborator UNKNOWN

• Guanxian People's Hospital

  collaborator UNKNOWN

• Yueyue Li

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2028-02-01

Completion

2028-02-01

Countries

• China

Study Locations