Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori

Study Overview
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Brief Summary
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Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1), especially 47-66% in China.

Conditions
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Helicobacter Pylori Eradication Rate

Intervention / Treatment
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* Drug: Modified non-clarithromycin triple therapy
* Drug: Sequential therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were intend to undergo upper endoscopy for any purpose and volunteered to written inform consent. Exclusion Criteria: negative in rapid urease test (RUT) previous standard eradication therapy for H. pylori; history of esophagectomy or gastrectomy; gastrointestinal malignancy; contraindications or allergic to study drugs; user of taking medicine that may affect the result of the study within 4 weeks (e.g., proton-pump inhibitors, H2-receptor antagonists, bismuth or antibiotics etc.); cardiopulmonary, hepatic or renal insufficiency, and/or severe current diseases or malignancy; pregnant or lactating women; participants of other trial within the past 3 months; unwilling or unable to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Modified non-clarithromycin triple therapy<br>H.pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days. | Drug: Modified non-clarithromycin triple therapy<br>* H. pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.<br>|
| Active Comparator: Sequential therapy<br>H.pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days. | Drug: Sequential therapy<br>* H. pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference of eradication rates between 2 groups |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the different rates of adverse events between 2 groups |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Sequential therapy, Modified non-clarithromycin triple therapy