Amoxicillin, Helicobacter Infection, Vonoprazan
Conditions
Brief summary
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
DRUG10-day group
vonoprazan 20mg tid and amoxicillin 1000mg tid for 10 days
DRUG14-day group
vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 70 years, no restriction on gender 2. Current Helicobacter pylori infection (positive result of either ¹³C or ¹⁴C urea breath test) 3. No prior history of Helicobacter pylori eradication therapy
Exclusion criteria
1. Severe underlying diseases, including hepatic insufficiency, renal insufficiency, malignant tumors, etc. 2. Active gastrointestinal bleeding 3. History of upper gastrointestinal surgery 4. History of allergy to study medications 5. Use of bismuth agents or antibiotics within 4 weeks prior to enrollment; use of acid-suppressive agents within 2 weeks prior to enrollment 6. Pregnant or breastfeeding women, and subjects who refuse to take contraceptive measures during the trial 7. Behaviors that may increase disease risks, such as chronic alcohol abuse and drug addiction 8. Subjects who are unable or unwilling to sign the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rates | immediately after the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse reactions | immediately after the procedure | — |
| Patient compliance | immediately after the procedure | Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken. |
Outcome results
None listed