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

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ClinicalTrials.gov Identifier: NCT03572777
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Collaborators:
University Hospital of Split
University of Split, School of Medicine
Information provided by (Responsible Party):
Antonio Mestrovic, University of Split, School of Medicine

Brief 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 174 patients (87 patients in each therapy group), and the planned duration is 6 months.


Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Concomitant therapy Drug: Hybrid therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study: Concomitant Versus Hybrid Therapy in the Treatment of Helicobacter Pylori Infection
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : October 15, 2018
Estimated Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Helicobacter pylori status one month after treatment. [ Time Frame: One month after finishing with therapy. ]
    Helicobacter pylori status (positive or negative), will be measured by stool test, one month after finishing with therapy.


Secondary Outcome Measures :
  1. Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection. [ Time Frame: One month after finishing with therapy. ]
    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

  2. Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection. [ Time Frame: One month after finishing with therapy. ]
    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).


Other Outcome Measures:
  1. Quality of life before and after eradication therapy [ Time Frame: One month after 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

  2. Quality of life before and after eradication therapy between hybrid and concomitant group. [ Time Frame: One month after therapy ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572777


Contacts
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Contact: Antonio Meštrović, MD +385 98 9123462 antonio.mestrovic1@gmail.com
Contact: Ante Tonkić, Prof. ante.tonkic@mefst.hr

Locations
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Croatia
University Hospital Centre Split Recruiting
Split, Croatia, 21210
Contact: Antonio Meštrović, MD    +385 21 556019      
Sponsors and Collaborators
Antonio Mestrovic
University Hospital of Split
University of Split, School of Medicine
Investigators
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Principal Investigator: Antonio Meštrović, MD University Hospital Centre Split, Croatia

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Responsible Party: Antonio Mestrovic, Sponsor-Investigator, University of Split, School of Medicine
ClinicalTrials.gov Identifier: NCT03572777     History of Changes
Other Study ID Numbers: 003-08/18-03/0001
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Mestrovic, University of Split, School of Medicine:
Helicobacter pylori, eradication, hybrid therapy, concomitant therapy
Additional relevant MeSH terms:
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Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Communicable Diseases
Helicobacter Infections
Amoxicillin
Metronidazole
Clarithromycin
Esomeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors