14-day Quadruple Therapy Versus Triple Therapy in HP Eradication

Study Overview
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Brief Summary
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In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. pylori infection in Tunisian patients.

Detailed Description
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This study includes male and female patients aged between 18 and 65, with documented Hp infection and who have had no previous eradication treatment.The diagnosis of Hp infection was made through an anatomopathological study. Gastric biopsies were taken according to the Sydney protocol: two fundics in one pot, two antrals and one at the angle of the lesser curve in a second pot. The biopsies were studied by an experienced anatomopathologist. The included patients were randomly divided into two treatment groups according to a 1: 1 ratio: the first group received concomitant quadruple therapy (QC) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. The second group received triple therapy (TT) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. H. pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment.

Official Title
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A Double Blind Randomized Study for Treatment of Helicobacter Pylori Infection: 14-day Non-bismuth Quadruple Therapy Versus Triple Therapy.

Conditions
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Gastritis H Pylori

Intervention / Treatment
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* Drug: metronidazole based quadriple therapy
* Drug: placebo based quadriple therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged between 18 and 65, with documented Hp infection. Exclusion Criteria: are excluded patients: With Cirrhosis. With Renal failure (serum creatinine> 120 µmol / L). Having complicated peptic ulcer (stenosis or hemorrhage or perforation) in an acute phase. Having severe psychiatric disorders. Having had gastric surgery in their history. Having already received an HP eradication treatment. Having received an antibiotic within the last two weeks. Who are allergic to one of the antibiotics used in the anti-Hp cure. Who are drug addicted.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: concomitant quadruple therapy (QC)<br>PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days | Drug: metronidazole based quadriple therapy<br>* patient randomized in QC will be treated by a double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day)<br>* Other names: concomitant quadruple therapy (QC);|
| Placebo Comparator: triple therapy (TT)<br>PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) AND PLACEBO for 14 days. | Drug: placebo based quadriple therapy<br>* patient randomized in TT will be treated by double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), clarithromycin (500 mg x 2 per day) and a placebo of metronidazole.<br>* Other names: Triple therapy (TT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HP eradiction rate | assessment by breath test | 6 weeks after completion of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of adverse reactions | we will determinate the percentage of adverse reactions in each group of treatment. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breath Tests, Helicobacter pylori