This is a multicenter non-inferiority randomized controlled trial for patients infected with Helicobacter pylori. Eligible participants will be randomly split into two groups. One group will take high-dose vonoprazan combined with amoxicillin (vonoprazan 20mg tid, amoxicillin 1000mg bid) for 10 days, while the other group will receive standard-dose vonoprazan plus amoxicillin (vonoprazan 20mg bid, amoxicillin 1000mg bid) for 14 days. The main goal of this study is to compare how well the two treatment plans clear the H. pylori bacteria. We aim to check if the 10-day high-dose treatment works no worse than the 14-day standard treatment. Every participant will take a follow-up test after treatment to see if the bacteria have been eliminated.
Aged 18 to 70 years, no restriction on gender
Current Helicobacter pylori infection (positive result of either ¹³C or ¹⁴C urea breath test)
No prior history of Helicobacter pylori eradication therapy
Severe underlying diseases, including hepatic insufficiency, renal insufficiency, malignant tumors, etc.
Active gastrointestinal bleeding
History of upper gastrointestinal surgery
History of allergy to study medications
Parallel
10-day group
Drugvonoprazan 20mg tid and amoxicillin 1000mg tid for 10 days
14-day group
Drugvonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
Eradication rates
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medicines. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Rate of adverse reactions
Patient compliance
Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
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This trial is not recruiting at the moment. You can still explore other options:
