Helicobacter
Conditions
Keywords
dual therapy, short term
Brief 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.
Interventions
DRUG7-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.
DRUG14-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
Yueyue Li
Qilu Hospital of Shandong University
Shandong University of Traditional Chinese Medicine
Zaozhuang Municipal Hospital
Qilu Hospital of Shandong University, Dezhou Branch
Yantai Zhifu Hospital
Kashi Prefecture Hospital of Traditional Chinese Medicine
Guanxian People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants with Helicobacter pylori infection will be randomly assigned in a 1:1 ratio to one of two treatment groups: * A 7-day high-dose vonoprazan-amoxicillin dual therapy group: vonoprazan 20 mg three times daily + amoxicillin 1,000 mg three times daily, administered orally for 7 days. * A 14-day vonoprazan-amoxicillin dual therapy group: vonoprazan 20 mg twice daily + amoxicillin 1,000 mg three times daily, administered orally for 14 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eradication rate | 6 weeks after treatment |
Secondary
| Measure | Time frame |
|---|---|
| incidence of adverse events | immediately after treatment |
Countries
China
Outcome results
None listed