Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.

Detailed Description
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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.

Official Title
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Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori:a Prospective, Multicenter, Open Label, Randomized Controlled Study:

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Vonoprazan
* Drug: Amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages between 18 and 70 years; Sexes eligible for study: both; patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test; 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; voluntary to be involved in the study and written informed consent was obtained from all patients Exclusion Criteria: allergic reactions to the study drugs; patients with peptic ulcer; patients who underwent eradication therapy for Helicobacter pylori during the last six months; 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; patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants; patients who have history of esophageal or gastric surgery; pregnant or lactating women; patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies; Alcohol abusers MALT lymphoma of stomach or malignant tumor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high dose amoxicillin with vonoprazan group<br>vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days | Drug: Vonoprazan<br>* Potassium-competitive acid blocker<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>|
| Experimental: standard dose amoxicillin with vonoprazan group<br>vonoprazan 20mg bid and amoxicillin 1000mg bid for 14 days | Drug: Vonoprazan<br>* Potassium-competitive acid blocker<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>|
| Experimental: low dose amoxicillin with vonoprazan group<br>vonoprazan 20mg bid and amoxicillin 500mg tid for 14 days | Drug: Vonoprazan<br>* Potassium-competitive acid blocker<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | four to eight weeks after completion of the medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Within 7 days after completion of therapy | 
| Microbiota influence | Collect the tongue coating and feces of some patients for flora analysis | baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, dual therapy, eradication rate, safety, microbiota