NCT03572777

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Antonio Mestrovic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-04-15
• Primary completion: 2019-10-01
• Completion: 2019-10-15
• First posted: 2018-06-28
• Last updated: 2021-01-26

Locations

1 site across 1 country: Croatia