Efficacy Comparison of 10-Day High-Dose Versus 14-Day Standard-Dose Vonoprazan Plus Amoxicillin in Helicobacter Pylori Eradication: A Multicenter Non-Inferiority Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShandong University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 10-day group
  • 14-day group

Treatment groups

232 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators