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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572777
• Other study ID #: 003-08/18-03/0001
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: October 15, 2019

Study information

• Verified date: January 2021
• Source: University of Split, School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: October 15, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• Concomitant therapy
Amoxicillin ('Amoksicilin') 1 g bid 14 days.
• Concomitant therapy
Clarithromycin ('Makcin') 500 mg bid for 14 days
• Concomitant therapy
Metronidazole ('Medazol') 500 mg bid for 14 days
• Concomitant therapy
Esomeprazole ('Emanera') 40 mg bid for 14 days
• Hybrid therapy
Amoxicillin ('Amoksicilin') 1 g bid 14 days
• Hybrid therapy
Esomeprazole ('Emanera') 40 mg bid for 14 days
• Hybrid therapy
Clarithromycin ('Makcin') 500 mg bid for the last 7 days
• Hybrid therapy
Metronidazole ('Medazol') 500 mg bid for the last 7 days

Locations

Country	Name	City	State
Croatia	University Hospital Centre Split	Split

Sponsors (3)

Lead Sponsor	Collaborator
Antonio Mestrovic	University Hospital of Split, University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	One month after therapy
Other	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
Primary	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.
Secondary	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.
Secondary	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).	One month after finishing with therapy.