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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 10-day group, 14-day group.
- Who it may be relevant to
- Registry conditions: Helicobacter Infection, Vonoprazan, Amoxicillin. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Eradication Efficacy Between 10-Day High-Dose Vonoprazan and 14-Day Standard-Dose Vonoprazan Combined With Amoxicillin for Helicobacter Pylori: A Multicenter, Non-Inferiority Randomized Controlled Trial
Overview
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.
Interventions
- Drug 10-day group
vonoprazan 20mg tid and amoxicillin 1000mg tid for 10 days - Drug 14-day group
vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
Primary outcome measures
- Eradication rates [Time frame: immediately after the procedure]
Secondary outcome measures (2)
- Rate of adverse reactions [Time frame: immediately after the procedure]
- Patient compliance [Time frame: immediately after the procedure]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Use of bismuth agents or antibiotics within 4 weeks prior to enrollment; use of acid-suppressive agents within 2 weeks prior to enrollment
- Pregnant or breastfeeding women, and subjects who refuse to take contraceptive measures during the trial
- Behaviors that may increase disease risks, such as chronic alcohol abuse and drug addiction
- Subjects who are unable or unwilling to sign the informed consent form
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07720037 · KYLL-2026-01-003-2