Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy.

Official Title
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Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication.

Conditions
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Helicobacter Infection

Intervention / Treatment
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* Drug: pantoprazole
* Drug: bismuth
* Drug: metronidazole
* Drug: tetracycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: H. pylori infection Aged between 18-80 years Are willing to received eradication therapy for H. pylori Exclusion Criteria: Children and teenagers aged less than 18 years or over 80 years Previous eradication therapy for H. pylori History of gastrectomy Previous allergic reaction to antibiotics Use of prompt pump inhibitors and antibiotics in the recent 4 weeks Active upper GI bleeding in the recent 1 week Contraindication to treatment drugs Pregnant or lactating women Severe concurrent disease or malignancy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PBMT7<br>pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days | Drug: pantoprazole<br>* pantoprazole 40mg bid<br>Drug: bismuth<br>* bismuth 300mg qid<br>Drug: metronidazole<br>* metronidazole 500mg tid<br>Drug: tetracycline<br>* tetracycline 500mg qid<br>|
| Active Comparator: PBMT14<br>pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days | Drug: pantoprazole<br>* pantoprazole 40mg bid<br>Drug: bismuth<br>* bismuth 300mg qid<br>Drug: metronidazole<br>* metronidazole 500mg tid<br>Drug: tetracycline<br>* tetracycline 500mg qid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether the two week group yield a higher eradication rate comparing to the one week group. |  | At least four week after completion of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effect |  | four weeks after completion of medication | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Bismuth, Salvage treatment, Metronidazole