Comparison of Hybrid and Bismuth Quadruple Therapies for Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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According the Maastricht IV consensus report publish in the Gut 2012, bismuth containing quadruple therapy was suggested to be the first choice for eradication therapy of Helicobacter pylori in the area with high clarithromycin resistance. Whether hybrid therapy or 14-day bismuth containing quadruple therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 14-day hybrid therapy and 14-day bismuth containing quadruple therapy in first-line treatment.

Detailed Description
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For this randomly assigned to receive either a 14-day hybrid therapy (a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days) or a 14-day bismuth containing quadruple therapies (pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days).at a 1:1 ratio. Our primary outcomes was the eradication rate by intention-to-treat and per- protocol analyses

Official Title
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Comparison of Hybrid and Bismuth Containing Quadruple Therapies for Helicobacter Pylori Eradication: a Randomized Controlled Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Bismuth quadruple therapy
* Drug: Hybrid therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis Exclusion Criteria: previous H pylori-eradication therapy ingestion of antibiotics or bismuth within the prior 4 weeks patients with allergic history to the medications used patients with previous gastric surgery the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia) pregnant women

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bismuth quadruple therapy<br>pantoprazole 40 mg bid for 14 days, bismuth subcitrate 120 mg qid for 14 days, tetracycline 500 mg qid for 14 days, metronidazole 250 mg qid for 14 days | Drug: Bismuth quadruple therapy<br>* pantoprazole 40 mg bid for 14 days, bismuth subcitrate 120 mg qid for 14 days, tetracycline 500 mg qid for 14 days, metronidazole 250 mg qid for 14 days<br>* Other names: metronidazole;|
| Active Comparator: Hybrid therapy<br>(pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days) followed by (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days, clarithromycin 500 mg bid for 7 days, and metronidazole 500 mg bid for 7 days) | Drug: Hybrid therapy<br>* (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days) followed by (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days, clarithromycin 500 mg bid for 7 days, and metronidazole 500 mg bid for 7 days)<br>* Other names: metronidazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Which H. Pylori Was Eradicated | Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status. | at the 6th week after the end of anti- H. pylori therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Hybrid therapy, Bismuth containing quadruple therapy, Eradication