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

Phase 1

• Conditions: The purpose of the study is to determine the effectiveness of two first-line treatment regimens for Helicobacter pylori.; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2019-001914-41-SI
• Lead Sponsor: Slovensko Združenje za gastroenterologijo in hepatologijo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-29
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 280

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified