Clinical trial NCT03572777: Comparison of Therapy in Treatment of Patients With Helicobacter Pylori Infection: Concomitant Versus Hybrid Therapy.
Official title: A Randomized Controlled Study: Concomitant Versus Hybrid Therapy in the Treatment of Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori, eradication, hybrid therapy, concomitant therapy
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
Collaborators: name: University Hospital of Split
name: University of Split, School of Medicine
First posted: 2018-06-28
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 120 patients (60 patients in each therapy group), and the planned duration is 12 months.


Eligibility 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

Primary outcomes:
measure: Helicobacter pylori status one month after treatment.
timeFrame: One month after finishing with therapy.
Secondary outcomes:
measure: Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.
timeFrame: One month after finishing with therapy.
measure: Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.
timeFrame: One month after finishing with therapy.
Other outcomes:
measure: Quality of life before and after eradication therapy
timeFrame: One month after therapy
measure: Quality of life before and after eradication therapy between hybrid and concomitant group.
timeFrame: One month after therapy
Locations:
city: Split
country: Croatia
facility: University Hospital Centre Split
Study officials:
affiliation: University Hospital Centre Split, Croatia
name: Antonio Meštrović, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.