Comparing Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinadizole on Treatment Helicobacter Pylori

Study Overview
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Brief Summary
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Comparison Efficacy of 10-days Therapy with Doxycycline with Bismuth Subsalicylate Versus Levofloxacine with Tinadizole on Eradication of Helicobacter Pylori in Syrian population.

Official Title
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Comparing the Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Doxycycline
* Drug: Levofloxacin 500mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods: Positive rapid urease test (CLOtest). Histologic evidence of H. pylori by modified Giemsa staining. Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy. Exclusion Criteria: Children and teenagers aged less than 18 years. Previous eradication treatment for H. pylori. Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics. History of gastrectomy. Gastric malignancy, including adenocarcinoma and lymphoma, Previous allergic reaction to antibiotics (Amoxicillin, Tinadizole, Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole). Contraindication to treatment drugs. Pregnant or lactating women. Severe concurrent disease. Liver cirrhosis.

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doxycyclien<br>Measure eradication rate of Helicobacter pylori infection with Doxycycline and bismuth subsalicylate | Drug: Doxycycline<br>* Doxycylcine 100 mg bid ,esomprazole 20 bid,Bismuth subsalicylate 262 tab.2 tab q.i.d,Tinadizole 500 bid<br>* Other names: Bismuth subsalicylate;|
| Active Comparator: Levofloxacine<br>Measure eradication rate of Helicobacter pylori infection with Livofloxacine and tinadizole | Drug: Levofloxacin 500mg<br>* Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid<br>* Other names: Tinadiole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of Helicobacter pylori infection | Eradication rate of Helicobacter infected patients | 8 week from begning of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Doxycyclien, Bismuth Subsalicylate, Helicobacter Pylori, levofloxacine, tinadizole