Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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This study aims to evaluate the efficacy of vonoprazan compared with esomeprazole as first-line treatment for Helicobacter Pylori(Hp) eradication, as well as the safety and economic benefits.

Detailed Description
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Vonoprazan, a novel potassium-competitive acid blocker, is proved to be superior to proton pump inhibitor in gastric acid-related diseases such as reflux esophagitis, as the increase of intragastric pH maintains for a longer period. Vonoprazan, therefore, is a promising candidate in helicobacter pylori eradication as the antibiotic resistance is rising. This study will enroll 234 patients, and randomly assigned by computer to one of the three treatment groups. Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days Participants will visit the clinic for a follow-up assessment 6-8 weeks after the course of treatments.

Official Title
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Efficacy and Safety of Furazolidone-based Quadruple Therapy With Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication: A Prospective Randomized Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Vonoprazan
* Drug: Esomeprazole
* Drug: Colloidal bismuth pectin
* Drug: Amoxicillin
* Drug: Furazolidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Helicobacter pylori-positive participants determined by ¹³C-urea breath test, ¹⁴C-urea breath test, HE stain or bacterium culture With no historical treatment for helicobacter pylori infection. Exclusion Criteria: Administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion Active peptic ulcer with complications such as hemorrhage, perforation, obstruction, cancerization, etc. With previous esophageal or gastric surgery With severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases Allergy to any of the study drugs Pregnancy or in lactation Participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher

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: Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days<br>Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 10days | Drug: Vonoprazan<br>* Potassium-competitive acid blocker<br>Drug: Colloidal bismuth pectin<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>Drug: Furazolidone<br>* Antibiotic for H. pylori eradication<br>|
| Experimental: Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days<br>Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days | Drug: Vonoprazan<br>* Potassium-competitive acid blocker<br>Drug: Colloidal bismuth pectin<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>Drug: Furazolidone<br>* Antibiotic for H. pylori eradication<br>|
| Active Comparator: Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days<br>Esomeprazole 20 mg bid, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days | Drug: Esomeprazole<br>* Proton pump inhibitor<br>Drug: Colloidal bismuth pectin<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>Drug: Furazolidone<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 six to eight weeks after completion of the medication. | Six to eight weeks after completion of the medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Adverse Drug Reaction(ADR) | Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, vonoprazan