Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection

Study Overview
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Brief Summary
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This study aims to evaluate the efficacy of dual therapy compared with bismuth-containing quadruple therapy as first-line treatment for Helicobacter Pylori eradication, as well as the safety and economic benefits.

Official Title
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Ten-day Amoxicillin-containing Dual Therapy as First-line Helicobacter Pylori Treatment in Elderly Patients: a Randomized Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Vonoprazan
* Drug: Rabeprazole
* Drug: Amoxicillin
* Drug: Clarithromycin
* Drug: Colloidal bismuth pectin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: having H. pylori related chronic gastritis confirmed by ¹³C-urea breath test, ¹⁴C-urea breath test and/or biopsy； underwent gastroscopy within 1 year before treatment, liver and renal function tests and electrocardiogram within 3 months before treatment； 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 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 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: 60 Years
Maximum Age: 80 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: groupA: dual therapy (vonoprazan+amoxicillin)<br>vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days | Drug: Vonoprazan<br>* Potassium-competitive acid blocker<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>|
| Experimental: group B: dual therapy (rabeprazole+amoxicillin)<br>rabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days | Drug: Rabeprazole<br>* Proton pump inhibitor<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>|
| Active Comparator: group C: bismuth-containing quadruple therapy<br>rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days | Drug: Rabeprazole<br>* Proton pump inhibitor<br>Drug: Amoxicillin<br>* Antibiotic for H. pylori eradication<br>Drug: Clarithromycin<br>* Antibiotic for H. pylori eradication<br>Drug: Colloidal bismuth pectin<br>* Gastric mucosal protective drug with anti-H. pylori effect<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. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. | 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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dual therapy, bismuth-containing quadruple therapy, Helicobacter Pylori