Comparison of Therapy in Treatment of Patients With Helicobacter Pylori Infection: Concomitant Versus Hybrid Therapy.
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Drug: Concomitant therapyDrug: Hybrid therapy
- Registration Number
- NCT03572777
- Lead Sponsor
- Antonio Mestrovic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 159
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Concomitant therapy Concomitant therapy Amoxicillin ('Amoksicilin') 1 g bid, metronidazole ('Medazol')500 mg bid, clarithromycin ('Makcin')500 mg bid and esomeprazole ('Emanera')40 mg bid for 14 days. Hybrid therapy Hybrid therapy 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.
- Primary Outcome Measures
Name Time Method Helicobacter pylori status one month after treatment. One month after finishing with therapy. Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.
- Secondary Outcome Measures
Name Time Method Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection. One month after finishing with therapy. 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
Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection. One month after finishing with therapy. 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).
Trial Locations
- Locations (1)
University Hospital Centre Split
🇭🇷Split, Croatia