Prospective randomised trial of first line treatments of Helicobacter pylori infection in Slovenia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001914-41-SI

Enrollment

280

Registered

2019-10-29

Start date

2020-03-09

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The purpose of the study is to determine the effectiveness of two first-line treatment regimens for Helicobacter pylori.

Interventions

Trade Name: Emozul Product Name: Emozul Pharmaceutical Form: Film-coated tablet Trade Name: Fromilid Product Name: Fromilid Pharmaceutical Form: Film-coated tablet Trade Name: Hiconcil Product Name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients 18 to 80 years old. Patients have not received proton pump inhibitors for the past 14 days. Patients did not receive antibiotics last month. Helicobacter pylori infection was demonstrated with a rapid urease test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 280 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: Pre-treatment of Helicobacter pylori infection. Defects in blood clotting, for example taking anticoagulant medicines that make it impossible to take biopsies. Drug allergy used in the study. Pregnancy, breastfeeding. Psychiatric illness that would make it impossible to participate in the research. Active treatment for malignancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparison of the efficacy of two first-line therapy regimens in patients with H. pylori infection.;Secondary Objective: to determine primary resistance of H. pylori to antibiotics in Slovenia;Primary end point(s): Comparison of the efficacy of two first-line therapy regimens in patients with H. pylori infection;Timepoint(s) of evaluation of this end point: 14 days	—

Secondary

Measure	Time frame
Secondary end point(s): to determine primary resistance of H. pylori to antibiotics in Slovenia;Timepoint(s) of evaluation of this end point: at the beginning of the treatment with antibiogram	—

Countries

Slovenia

Contacts

Public Contactprof. Tepeš

Abakus medico d.o.o.

bojan.tepes@siol.net38638191411

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026