Investigators will enroll treatment-naïve H. pylori-positive patients according to the inclusion and exclusion criteria in the trial. After obtaining written informed consent, investigators will open envelopes labeled with corresponding subject numbers in the order of subject enrollment to determine group allocation. Subjects will receive interventions according to their assigned regimens: the 14-day vonoprazan-amoxicillin dual therapy regimen, the 14-day vonoprazan-tetracycline dual therapy regimen, or the 14-day vonoprazan-minocycline dual therapy regimen.
Meanwhile, investigators will complete the case report forms (CRFs) to record subjects' basic demographic information and risk factors for eradication failure. Subjects will be asked to fill out patient diaries to document medication administration and adverse reactions. After trial initiation, investigators will follow up with subjects via telephone or WeChat and collect patient diaries, summarize medication status and adverse reactions during treatment, and assess subject compliance.
Six weeks after the end of treatment, subjects will undergo a repeat ¹³C-urea breath test. Investigators will record treatment outcomes and re-examination results, finalize the case report forms, and upload photographs of original examination documents.
After all subjects finish the trial, the eradication rate, incidence of adverse events and subject compliance in each group will be calculated. Statistical analyses will be performed to compare demographic characteristics and risk factors between patients with eradication success and eradication failure. The findings will provide evidence for the selection of H. pylori eradication regimens.
Aged 18-65 years, male or female.
Helicobacter pylori-infected patients with positive ¹³C/¹⁴C urea breath test, and at least one positive result among the following three tests: Rapid Urease Test; Histopathological examination of gastric mucosal biopsy specimens; Stool Hp antigen test.
No prior history of Helicobacter pylori eradication therapy.
Severe underlying diseases, such as hepatic insufficiency, renal insufficiency, malignant tumors, etc.
Active gastrointestinal bleeding.
History of upper gastrointestinal surgery.
History of allergy to study medications.
Parallel
Vonoprazan-Amoxicillin Dual Therapy
DrugMedication Regimen: Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals. Amoxicillin Capsules: 4 capsules (0.25 g each) three times daily, taken immediately after meals. Treatment duration:14 days
Vonoprazan-Tetracycline Dual Therapy
DrugMedication Regimen: Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals. Tetracycline Capsules: 2 capsules (0.25 g each) three times daily, taken immediately after meals. Treatment duration:14 days
Vonoprazan-Minocycline Dual Therapy
DrugMedication Regimen: Vonoprazan Fumarate Tablets: 1 tablet (20 mg) twice daily, taken 30 minutes before meals. Minocycline Hydrochloride Capsules: 2 capsules (50 mg each) twice daily, taken immediately after meals. Treatment duration:14 days
¹³C-urea breath test
Adverse event rate
Participant compliance
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