Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment

Study Overview
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Brief Summary
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To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.

Detailed Description
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The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

Official Title
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Levofloxacin-containing Therapy for Helicobacter Pylori Treatment

Conditions
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Functional Dyspepsia, Peptic Ulcer

Intervention / Treatment
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* Drug: Bismuth
* Drug: Lansoprazole
* Drug: Levoﬂoxacin
* Drug: Amoxicillin


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 ulcer Exclusion Criteria: patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications

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 |
| --- | --- |
| Active Comparator: Levofloxacin-triple therapy<br>Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin | Drug: Lansoprazole<br>* Lansoprazole 30 mg b.i.d.for 2 weeks<br>* Other names: Proton Pump Inhibitor;Drug: Levoﬂoxacin<br>* Levoﬂoxacin 0.5 q.d. for 2 weeks<br>Drug: Amoxicillin<br>* Amoxicillin 1 g b.i.d. for 2 weeks<br>|
| Experimental: Levofloxacin-quadruple therapy<br>Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin | Drug: Bismuth<br>* Bismuth 220mg b.i.d for 2 weeks<br>* Other names: Bismuth potassium citrate;Drug: Lansoprazole<br>* Lansoprazole 30 mg b.i.d.for 2 weeks<br>* Other names: Proton Pump Inhibitor;Drug: Levoﬂoxacin<br>* Levoﬂoxacin 0.5 q.d. for 2 weeks<br>Drug: Amoxicillin<br>* Amoxicillin 1 g b.i.d. for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eradication rate of Helicobacter pylori |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eradication, helicobacter pylori, bismuth