Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection

Study Overview
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Brief Summary
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This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.

Detailed Description
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Multiple regimens have been evaluated for H. pylori therapy in randomized controlled trials The treatment regimen that is selected must be effective, but considerations such as cost, side effects, and ease of administration should also be taken into account. Despite the number of studies, the optimal therapeutic regimen has not yet been defined. The regimen most commonly recommended for first line treatment of H. pylori is triple therapy with a PPI, amoxicillin and clarithromycin for 14 days. However, the multi-drug application is associated with remarkable side effects and it is not uncommon not to be able to complete a treatment course. Thus, treatment failure is associated with H. pylori strains that are resistant to the commonly used antibiotics. This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.

Official Title
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Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection

Conditions
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Helicobacter Infection

Intervention / Treatment
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* Drug: Nexium
* Drug: Tinafas
* Drug: Tavanex
* Drug: Lanzol
* Drug: Klacid
* Drug: Iramox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients who proved H. pylori infection following three methods Positive rapid urease test Histologic evidence of H. pylori by modified Giemsa staining Positive stool Antigen Test Exclusion Criteria: Patients who received eradication therapy for H. pylori infection, previously H. pylori eradication failure because of poor compliance The administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks Advanced gastric cancer or other malignancy Abnormal liver function or liver cirrhosis Abnormal renal function or chronic kidney disease Other severe concurrent diseases Previous allergic reactions to the study drugs Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 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: Tavanex & Nexium & Tinafas<br>Patients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days | Drug: Nexium<br>* Patients in experimental group will receive the 14 day single dose of Nexium 40 mg daily<br>* Other names: Esomeprazole;Drug: Tinafas<br>* Patients in experimental group will receive the 14 day single dose regimen of Tinafas 1 g daily<br>* Other names: Tinidazole;Drug: Tavanex<br>* Patients in experimental group will receive the 14 day single dose of Tavanex 500 mg daily<br>* Other names: Levofluxacine;|
| Active Comparator: Lanzol & Klacid &Iramox<br>Patients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days | Drug: Lanzol<br>* Patients in active comparator group will receive the 14 day lansoprazole (Lanzol) 30 mg twice daily<br>* Other names: lansoprazole;Drug: Klacid<br>* Patients in active comparator group will receive the 14 day clarithromycin (Klacid) 500 mg twice daily twice daily<br>* Other names: clarithromycin;Drug: Iramox<br>* Patients in active comparator group will receive the 14 day amoxicillin (Iramox) 1 g twice daily<br>* Other names: amoxicillin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of H.pylori eradication | Breath Urea Test | 42 days after study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Compliance | Interview | within the first week after study completion |