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Completed

NCT Number: NCT03572777

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Centre Split

Split, 21210, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

concomitant therapy

Drug

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

Hybrid therapy

Drug

Amoxicillin ('Amoksicilin') 1 g bid 14 days

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Antonio Mestrovic

Other

Collaborators

  • University Hospital of Split
  • University of Split, School of Medicine

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2018
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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