The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
900
Potassium-competitive acid blocker
Antibiotic for H. pylori eradication
Changshu No.1 People's Hospital
Changshu, Jiangsu, China
Changzhou Traditional Chinese Medicine Hospital
Changzhou, Jiangsu, China
The first people's hospital of Lianyungang
Lianyungang, Jiangsu, China
Helicobacter pylori eradication rate
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.
Time frame: four to eight weeks after completion of the medication
Adverse event
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.
Time frame: Within 7 days after completion of therapy
Compliance Rate
Compliance was defined as poor when they had taken less than 80% of the total medication
Time frame: Within 7 days after completion of therapy
Microbiota influence
Collect the tongue coating and feces of some patients for flora analysis
Time frame: baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy
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Jiangsu Province Hospital on Integration of Chinese and Western Medicine
Nanjing, Jiangsu, China
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing Jiangbei Hospital
Nanjing, Jiangsu, China
Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Taixing People's Hospital
Taishing, Jiangsu, China
The Fourth People's Hospital of Taizhou
Taizhou, Jiangsu, China
...and 3 more locations