Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori

Study Overview
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Brief Summary
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The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

Detailed Description
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The success rate of currently recommended triple therapy with a proton pump inhibitor (PPI) plus amoxicillin and clarithromycin has fallen into the unacceptable range. The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment, while ten day triple therapy is used as control.

Conditions
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Functional Dyspepsia, Peptic Ulcer, Helicobacter Pylori

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Amoxicillin
* Drug: Clarithromycin
* Drug: Bismuth Potassium Citrate
* Other: long duration (14 day)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcers Exclusion Criteria: patients less than 18 years old, with history of H. pylori infection treatment, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks, or allergy to any one of the given medication in the regimens.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: 10 day Quadruple Therapy<br>Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days | Drug: Esomeprazole<br>* antisecretary drug of the quadruple therapy<br>* Other names: proton pump inhibitor;Drug: Amoxicillin<br>* antibiotic of the quadruple therapy<br>* Other names: antibiotic;Drug: Clarithromycin<br>* antibiotic of the quadruple therapy<br>* Other names: antibiotic;Drug: Bismuth Potassium Citrate<br>* one of a component of a quadruple therapy<br>* Other names: Bismuth;|
| Active Comparator: 10 day Triple therapy<br>Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days | Drug: Esomeprazole<br>* antisecretary drug of the quadruple therapy<br>* Other names: proton pump inhibitor;Drug: Amoxicillin<br>* antibiotic of the quadruple therapy<br>* Other names: antibiotic;Drug: Clarithromycin<br>* antibiotic of the quadruple therapy<br>* Other names: antibiotic;|
| Active Comparator: 14 day quadruple therapy<br>Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days | Drug: Esomeprazole<br>* antisecretary drug of the quadruple therapy<br>* Other names: proton pump inhibitor;Drug: Amoxicillin<br>* antibiotic of the quadruple therapy<br>* Other names: antibiotic;Drug: Clarithromycin<br>* antibiotic of the quadruple therapy<br>* Other names: antibiotic;Drug: Bismuth Potassium Citrate<br>* one of a component of a quadruple therapy<br>* Other names: Bismuth;Other: long duration (14 day)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of Helicobacter pylori | To calculate and compare the efficacy of 10 day and 14 day triple therapies with and without bismuth,to examine whether long duration and addition of bismuth affects the eradication. | 2 months |