Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori, dual therapy, eradication rate, safety, microbiota
Brief summary
The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.
Detailed description
This study intends to select the patients with Hp infection in 13 tertiary hospitals across our country, and randomly give the three therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with H.pylori infection. Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.
Interventions
DRUGVonoprazan
Potassium-competitive acid blocker
DRUGAmoxicillin
Antibiotic for H. pylori eradication
Sponsors
Nanjing First Hospital, Nanjing Medical 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. Ages between 18 and 70 years; Sexes eligible for study: both; 2. patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test; 3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months; 4. voluntary to be involved in the study and written informed consent was obtained from all patients
Exclusion criteria
1. allergic reactions to the study drugs; 2. patients with peptic ulcer; 3. patients who underwent eradication therapy for Helicobacter pylori during the last six months; 4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment; 5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants; 6. patients who have history of esophageal or gastric surgery; 7. pregnant or lactating women; 8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies; 9. Alcohol abusers 10. MALT lymphoma of stomach or malignant tumor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Helicobacter pylori eradication rate | four to eight weeks after completion of the medication | Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | Within 7 days after completion of therapy | Adverse drug reactions are classified into six types: dose-related, non-dose-related, dose-related and time-related, time-related, withdrawal, and failure of therapy. |
| Compliance Rate | Within 7 days after completion of therapy | Compliance was defined as poor when they had taken less than 80% of the total medication |
| Microbiota influence | baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy | Collect the tongue coating and feces of some patients for flora analysis |
Countries
China
Outcome results
None listed