Sequential Therapy Versus Quadruple Therapy in H. Pylori Eradication

Study Overview
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Brief Summary
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The investigators aimed to compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the first line and second line treatment assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora assess the impact of eradication therapy on the metabolic factors

Detailed Description
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Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection reduces the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. Sequential therapy for 10 days has been shown to be more effective than triple therapy for 7 and 10 days. The investigators further demonstrated that sequential therapy given for 14 days was superior to triple therapy given for 14 days. Recently, the investigators also found that bismuth quadruple therapy given for 10 days appeared to be more effective than triple therapy given for 14 days in the first line therapy. However, whether sequential therapy given for 14 days is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown.

Official Title
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Comparison of the Efficacy of Sequential Therapy and Bismuth Quadruple Therapy in the First Line and Second Line Therapy for Helicobacter Pylori Infection- A Multi-center Randomized Trial

Conditions
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Helicobacter

Intervention / Treatment
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* Drug: 14-day sequential therapy
* Drug: Bismuth quadruple therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. H. pylori infected patients naïve to eradication therapies will be eligible in this study. Exclusion Criteria: children and teenagers aged less than 20 years, history of gastrectomy, gastric malignancy, including adenocarcinoma and lymphoma, previous allergic reaction to antibiotics (bismuth, amoxicillin, metronidazole, clarithromycin, tetracycline) and PPI (esomeprazole), contraindication to treatment drugs, pregnant or lactating women, severe concurrent disease, concomitant use of clopidogrel, or (9) Unwilling to accept random assignment of subjects

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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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: sequential therapy for 14 days (S14)<br>14 day sequential therapy | Drug: 14-day sequential therapy<br>* D1-D7: (esomeprazole 40mg qid + amoxicillin 500mg qid) for 7 days D8-D14: (esomeprazole 40mg qid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days<br>* Other names: S14;|
| Active Comparator: bismuth quadruple therapy (Q10)<br>Bismuth quadruple therapy | Drug: Bismuth quadruple therapy<br>* D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days<br>* Other names: Q10;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate: determined by urea breath test (13C-UBT, according to ITT analysis) | No eradicated divided by total cases by intention to treat analysis. 13C-UBT will be used to determine the H. pylori status at least 6 weeks after completion of treatment. A delta value of > 4 units will be defined as positive for H. pylori infection as our previous studies. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effect: occurrence of any adverse effect during the treatment | adverse effects related to treatment by per protocol analysis. The patients will be informed of the common side effects from the studied drugs prior to therapy. They will also be asked to record these symptoms during treatment. A standardized interview at the outpatient clinic at the end of treatment will be arranged. The adverse events and compliance will be assessed by the research staffs with pre-defined case report form. | 2 weeks | 
| changes of antibiotic resistance | changes of antibiotic resistance of E. coli by per protocol analysis | 2 weeks, 8 weeks, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy, safety, H. pylori eradication