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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Concomitant therapy; Drug: Concomitant therapy; Drug: Concomitant therapy; Drug: Concomitant therapy; Drug: Hybrid therapy; Drug: Hybrid therapy; Drug: Hybrid therapy; Drug: Hybrid therapy

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Split, Croatia, 21210
    • University Hospital Centre Split

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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.

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Antonio Mestrovic
• Collaborators: University Hospital of Split; University of Split, School of Medicine
• Investigators: Principal Investigator: Antonio Meštrović, MD, University Hospital Centre Split, Croatia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Helicobacter pylori, eradication, hybrid therapy, concomitant therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections
• Other Study ID Numbers: 003-08/18-03/0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No