Comparison of Therapy in Treatment of Patients With Helicobacter Pylori Infection: Concomitant Versus Hybrid Therapy.

Study Overview
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Brief Summary
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The aim of the study is to compare the effectiveness of two therapeutic protocols in the treatment of Helicobacter pylori infection. The hypothesis of our research is that the two therapeutic options (hybrid and concomitant therapy) will be equally successful in the treatment of Helicobacter pylori infection. In other words, in both therapeutic groups we expect successful treatment of Helicobacter pylori infection in or more than 90 % of patients. In other studies, both therapeutic options have the same efficacy in treating H. pylori infection. On the other had there are no studies available in Croatia to compare the effectiveness of these therapeutic options so far, which is the main objective of our research. The secondary goals of our study will be: the existence of differences in the occurrence of possible side effects, as well as the compliance between patients in both therapeutic options. It is also our aim to compare the quality of life of patients with Helicobacter pylori infection before and after treatment, via a questionnaire that is common for this purpose. The study is expected to include a total of 120 patients (60 patients in each therapy group), and the planned duration is 12 months.

Official Title
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A Randomized Controlled Study: Concomitant Versus Hybrid Therapy in the Treatment of Helicobacter Pylori Infection

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Concomitant therapy
* Drug: Concomitant therapy
* Drug: Concomitant therapy
* Drug: Concomitant therapy
* Drug: Hybrid therapy
* Drug: Hybrid therapy
* Drug: Hybrid therapy
* Drug: Hybrid therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Helicobacter pylori infection (documented by: positive antigen stool test, or positive urease rapid test obtained during upper endoscopy, or Helicobacter pylori in histological finding, or positive C-urea breath test; according to recent Maastricht V guidelines; written informed consent Exclusion Criteria: age under 18 previously treatment of Helicobacter pylori infection malignancy of stomach or other site history of taking proton pump inhibitors, H2 antagonist, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in previous month significant underlying disease (renal failure, psychiatric disorders) history of allergic reactions to any medications used in study refuse to participate in study breastfeeding and pregnancy quitting the study

Ages Eligible for Study
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Minimum Age: 18 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: Concomitant therapy<br>Amoxicillin ('Amoksicilin') 1 g bid, metronidazole ('Medazol')500 mg bid, clarithromycin ('Makcin')500 mg bid and esomeprazole ('Emanera')40 mg bid for 14 days. | Drug: Concomitant therapy<br>* Amoxicillin ('Amoksicilin') 1 g bid 14 days.<br>Drug: Concomitant therapy<br>* Clarithromycin ('Makcin') 500 mg bid for 14 days<br>Drug: Concomitant therapy<br>* Metronidazole ('Medazol') 500 mg bid for 14 days<br>Drug: Concomitant therapy<br>* Esomeprazole ('Emanera') 40 mg bid for 14 days<br>|
| Active Comparator: Hybrid therapy<br>Amoxicillin ('Amoksicilin') 1 g bid and esomeprazole ('Emanera') 40 mg bid for 14 days, with metronidazole ('Medazol')500 bid and clarithromycin ('Makcin') 500 mg bid for the last 7 days. | Drug: Hybrid therapy<br>* Amoxicillin ('Amoksicilin') 1 g bid 14 days<br>Drug: Hybrid therapy<br>* Esomeprazole ('Emanera') 40 mg bid for 14 days<br>Drug: Hybrid therapy<br>* Clarithromycin ('Makcin') 500 mg bid for the last 7 days<br>Drug: Hybrid therapy<br>* Metronidazole ('Medazol') 500 mg bid for the last 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori status one month after treatment. | Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy. | One month after finishing with therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection. | Compliance will be measured by counting pills that were taken during therapy. More than or equal 80 % of taken pills will be consider as good compliance | One month after finishing with therapy. | 
| Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection. | Patients will be ask to report any adverse effect occured during treatment. They will be divided in groups according to degree of limiting daily activities: no adverse effects; mild (no limit of activities); moderate (partially limited activities); severe (completely limited activities). | One month after finishing with therapy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, eradication, hybrid therapy, concomitant therapy