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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
159
Amoxicillin ('Amoksicilin') 1 g bid 14 days.
Clarithromycin ('Makcin') 500 mg bid for 14 days
Metronidazole ('Medazol') 500 mg bid for 14 days
Esomeprazole ('Emanera') 40 mg bid for 14 days
Amoxicillin ('Amoksicilin') 1 g bid 14 days
Esomeprazole ('Emanera') 40 mg bid for 14 days
Clarithromycin ('Makcin') 500 mg bid for the last 7 days
Metronidazole ('Medazol') 500 mg bid for the last 7 days
University Hospital Centre Split
Split, Croatia
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.
Time frame: One month after finishing with therapy.
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
Time frame: 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).
Time frame: One month after finishing with therapy.
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