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

NCT03572777 | Completed

• 1 other identifier: 003-08/18-03/0001
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori, eradication, hybrid therapy, concomitant therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.

  One month after finishing with therapy.

• Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.

  One month after finishing with therapy.

Other Outcomes (2)

• Quality of life before and after eradication therapy

  One month after therapy

• Quality of life before and after eradication therapy between hybrid and concomitant group.

  One month after therapy

Study Arms (2)

Concomitant therapy

ACTIVE COMPARATOR

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

Hybrid therapy

ACTIVE COMPARATOR

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

Interventions

Concomitant therapy DRUG

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

Concomitant therapy

Hybrid therapy DRUG

Amoxicillin ('Amoksicilin') 1 g bid 14 days

Hybrid therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antonio Mestrovic: lead
• University Hospital of Split: collaborator
• University of Split, School of Medicine: collaborator

Study Sites (1)

University Hospital Centre Split

Split, 21210, Croatia

Location

Related Publications (1)

• 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.

  PMID: 33378403 DERIVED

MeSH Terms

Interventions

Hybrid Renal Replacement Therapy

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Antonio Meštrović, MD

  University Hospital Centre Split, Croatia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 28, 2018
• Study Start: April 15, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 15, 2019
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

CR (1)