Five Days Quadruple and Clarithromycin Containing Triple Therapy as Treatment for Helicobacter Pylori Eradication

Study Overview
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Brief Summary
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The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori eradication with a 5-day quadruple therapy versus a clarithromycin-containing triple therapy.

Detailed Description
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Eligible patients with H pylori infection were randomized to receive either five-day QUAD (esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.) or EAC (esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d.). H. pylori status was rechecked by 13C urea breath test 8 weeks after treatment. Patients who failed their respective therapy were invited to undergo H. pylori susceptibility testing and crossover to receive the alternative regimen for the same duration.

Official Title
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Five Days Quadruple and Clarithromycin Containing Triple Therapy as Empirical First and Second-Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Quadruple therapy
* Drug: Triple therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with H. pylori infection did not receive H. pylori eradication therapy before Exclusion Criteria: patients who have received previous H. pylori eradication therapy co-morbidity of liver cirrhosis co-morbidity of renal failure co-morbidity of alcoholism co-morbidity of malignancy received antibiotics, bismuth preparations, proton pump inhibitors or probiotic in the preceding three months patients with known allergy to the medications used patients with a history of previous gastrointestinal diseases or gastric surgery pregnancy

Ages Eligible for Study
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Minimum Age: 21 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quadruple therapy<br>First line: 5 days esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d. Cross over second line for those who failed first line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d | Drug: Quadruple therapy<br>* First line: 5 days esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d. Cross over second line for those who failed first line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d<br>|
| Active Comparator: Triple Therapy<br>First line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d Second line cross over if failed first line: 7 days quadruple therapy: esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.) | Drug: Triple therapy<br>* First line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d Second line cross over if failed first line: 7 days quadruple therapy: esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H pylori eradication | Successful H pylori eradication documented by urea breath test after first and second line treatments. Cross over if patients failed first line treatment | 8 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Assessed adverse effects and compliance by standard questionnaire upon 10 weeks outpatient follow-up | 10 weeks outpatient follow-up |