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| Name | Class |
|---|---|
| University Hospital of Split | OTHER |
| University of Split, School of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concomitant therapy | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concomitant therapy | Drug | Amoxicillin ('Amoksicilin') 1 g bid 14 days. |
| |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life before and after eradication therapy | Quality of life before and after eradication (both groups combined) therapy will be reported by The Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. GSRS questionnaire: 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents no discomfort at all, 2 - minor discomfort, 3 -mild discomfort, 4 - moderate discomfort, 5 -moderately severe discomfort, 6 -severe discomfort, 7 - very severe discomfort |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Meštrović, MD | University Hospital Centre Split, Croatia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Centre Split | Split | 21210 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33378403 | Derived | Mestrovic A, Perkovic N, Bozic J, Pavicic Ivelja M, Vukovic J, Kardum G, Puljiz Z, Tonkic A. Randomised clinical trial comparing concomitant and hybrid therapy for eradication of Helicobacter pylori infection. PLoS One. 2020 Dec 30;15(12):e0244500. doi: 10.1371/journal.pone.0244500. eCollection 2020. |
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| Concomitant therapy |
| Drug |
Clarithromycin ('Makcin') 500 mg bid for 14 days |
|
| Concomitant therapy | Drug | Metronidazole ('Medazol') 500 mg bid for 14 days |
|
| Concomitant therapy | Drug | Esomeprazole ('Emanera') 40 mg bid for 14 days |
|
| Hybrid therapy | Drug | Amoxicillin ('Amoksicilin') 1 g bid 14 days |
|
| Hybrid therapy | Drug | Esomeprazole ('Emanera') 40 mg bid for 14 days |
|
| Hybrid therapy | Drug | Clarithromycin ('Makcin') 500 mg bid for the last 7 days |
|
| Hybrid therapy | Drug | Metronidazole ('Medazol') 500 mg bid for the last 7 days |
|
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. |
| One month after therapy |
| Quality of life before and after eradication therapy between hybrid and concomitant group. | Quality of life before and after eradication therapy will be reported by the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire comparing both groups. GSRS questionnaire: 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents no discomfort at all, 2 - minor discomfort, 3 -mild discomfort, 4 - moderate discomfort, 5 -moderately severe discomfort, 6 -severe discomfort, 7 - very severe discomfort | One month after therapy |
| ID | Term |
|---|---|
| D000079782 | Hybrid Renal Replacement Therapy |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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