The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori

Study Overview
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Brief Summary
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The eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. The aim of this prospective study is to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.

Detailed Description
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In China, the first-line therapy to treat Helicobacter pylori (Hp) consists of a bismuth-based proton pump inhibitor (PPI) and two antibiotics for 14 days.But, eradication has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. Vonoprazan is a novel potassium-competitive acid blocker more effective in suppressing acid production than proton pump inhibitors (PPIs). Several studies previously suggested that vonoprazan containing antibiotic therapy was superior to other PPI-containing therapies for Hp. Most strains of Helicobacter pylori are sensitive to amoxicillin. Bismuth salts, a topical agent, which are available in our country, have a synergistic effect on antibiotics and decrease the bacterial load. Therefore, the investigators performed a prospective, multi-center, randomized trial, to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.

Official Title
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The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori: a Prospective, Multi-Center, Randomized Controlled Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Vonoprazan
* Drug: Amoxicillin
* Drug: Esomeprazole
* Drug: Amoxicillin
* Drug: Clarithromycin
* Drug: Bismuth potassium citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Helicobacter pylori infected patients comfirmed by 13C/14C UBT age 18 65 Exclusion Criteria: prior Hp eradication therapy including amoxicillin and clarithromycin previous gastric resection allergic to the drugs used in this study previous use of proton pump inhibitors, bismuth, H2 receptor antagonist or antibiotics, probiotics within 4 weeks of the study Patients who were pregnant or lactating Patients taking NSAIDs, alcoholic or with other serious disease (e.g. hepatopathy, heart disease, nephropathy#diabete mellitus, hypertension…) effect the evaluation of this study Can't express the complaint correctly

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Vonoprazan group<br>Vonoprazan + Amoxicillin + Bismuth potassium citrate Drug: Vonoprazan 20mg bid Other Names: no Drug: Amoxicillin 0.75g tid Other Names: no Drug: Bismuth potassium citrate 0.22g bid Other Names: no | Drug: Vonoprazan<br>* 20mg bid<br>Drug: Amoxicillin<br>* 0.75g tid<br>Drug: Bismuth potassium citrate<br>* 0.22g bid<br>|
| Active Comparator: control group: quadruple therapy<br>Drug: Esomeprazole 20mg bid Other Names: no Drug: Amoxicillin 1.0g bid Other Names: no Drug: Clarithromycin 0.5g bid Other Names:no Drug: Bismuth potassium citrate 0.22g bid Other Names:no | Drug: Esomeprazole<br>* 20mg bid<br>Drug: Amoxicillin<br>* 1.0g bid<br>Drug: Clarithromycin<br>* 0.5g bid<br>Drug: Bismuth potassium citrate<br>* 0.22g bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication | to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin and Bismuth for eradication of Hp, compared with standard quadruple therapy. | 6 weeks after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | to investigate the incidence of adverse events of Triple Therapy with Vonoprazan, Amoxicillin and Bismuth, compared with standard quadruple therapy. | 2 weeks and 6 weeks after treatment initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vonoprazan, Standard Quadruple Therapy