Efficacies of Tetracycline-levofloxacin, Standard Bismuth, Amoxicillin-levofloxacin Quadruple Therapy for H.p

Study Overview
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Brief Summary
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Compare the efficacy of Tetracycline combined with levofloxacin quadruple therapy, standard tincture quadruple therapy and amoxicillin combined with levofloxacin quadruple therapy on the second line of Helicobacter pylori sterilization. To investigate the drug resistance of Helicobacter pylori and the host genotypes of CYP2C19 and IL-1B-511 on the sterilizing effect of three second-line Helicobacter pylori.

Detailed Description
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The standard tincture quadruple therapy and the proton pump inhibitor combined with fluoroquinolone and amoxicillin triple therapy recommended by the 5th Mazdock-Florence Consensus Conference on the second line of Helicobacter pylori treatment The sterilization rate is not ideal (less than 80%). Recently, we have developed a Tetracycline combined with levofloxacin quadruple therapy for first-line treatment failure of H. pylori infection, with a relatively high sterilization rate (> 95%). A randomized controlled trial confirmed that the elimination rate of Tetracycline combined with levofloxacin quadruple therapy was better than proton pump inhibitor combined with fluoroquinolone after standard triple therapy and non-tank tetratherapy sterilization failure. Triple therapy with amoxicillin.

Official Title
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Efficacies of Tetracycline-levofloxacin Quadruple Therapy, Standard Bismuth Quadruple Therapy and Amoxicillin-levofloxacin Quadruple Therapy in the Second-line Treatment of H Pylori Infection

Conditions
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Helicobacter Pylori Eradication

Intervention / Treatment
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* Drug: esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin
* Drug: esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole
* Drug: esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 20 years old subject was failure for the first line therapy of Helicobacter pylori Exclusion Criteria: Those who are allergic to the drugs used in this study Those who have had a stomach surgery Those who have antibiotics within four weeks of treatment Those who have severe cirrhosis, uremia or malignancy Those who are a pregnant woman or a woman who breastfeeds

Ages Eligible for Study
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Minimum Age: 20 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
Interventional Model Description: 1.Tetracycline combined with levofloxacin quadruple therapy 2. standard tincture quadruple therapy 2. amoxicillin combined with levofloxacin quadruple therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tetracycline combined with levofloxacin quadruple therapy<br>esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ tetracycline 500mg four times a day+ levofloxacin 500mg once a day | Drug: esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin<br>* Tetracycline combined with levofloxacin quadruple therapy<br>|
| Active Comparator: standard tincture quadruple therapy<br>esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day + tetracycline 500mg four times a day + metronidazole 250mg four times a day | Drug: esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole<br>* standard tincture quadruple therapy<br>|
| Active Comparator: amoxicillin combined with levofloxacin quadruple therapy<br>esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ amoxicillin 500mg four times a day+ levofloxacin 500mg once a day | Drug: esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin<br>* amoxicillin combined with levofloxacin quadruple therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of Helicobacter pylori | evalute eradication outcome by 13C urea breath test | 6 week after finish study drugs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genotype analysis | CYP2C19 genotype, IL-1B-511 genotype | 2 weeks after finishing study drgus |