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

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.

Conditions

• Helicobacter Pylori Infection

Interventions

DRUG

Concomitant therapy

Amoxicillin ('Amoksicilin') 1 g bid 14 days.

DRUG

Concomitant therapy

Clarithromycin ('Makcin') 500 mg bid for 14 days

DRUG

Concomitant therapy

Metronidazole ('Medazol') 500 mg bid for 14 days

DRUG

Concomitant therapy

Esomeprazole ('Emanera') 40 mg bid for 14 days

DRUG

Hybrid therapy

Amoxicillin ('Amoksicilin') 1 g bid 14 days

DRUG

Hybrid therapy

Esomeprazole ('Emanera') 40 mg bid for 14 days

DRUG

Hybrid therapy

Clarithromycin ('Makcin') 500 mg bid for the last 7 days

DRUG

Hybrid therapy

Metronidazole ('Medazol') 500 mg bid for the last 7 days

Sponsors & Collaborators

• University Hospital of Split

  collaborator OTHER

• University of Split, School of Medicine

  collaborator OTHER

• Antonio Mestrovic

  lead OTHER

Principal Investigators

• Antonio Meštrović, MD · University Hospital Centre Split, Croatia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-15

Primary Completion

2019-10-01

Completion

2019-10-15

Countries

• Croatia

Study Locations