Prospective Randomised Trial of First and Second Line Treatments of RCT of First and Second Line H Pylori Treatments in Slovenia

• Status: Not yet recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Study is prospective randomised multicentric. The primary objective of the study is to compare the efficacy of two first-line therapy regimens and two second-line therapy regimens (ie, after failure of first-line treatment) in patients with H. pylori infection. The secondary objective of the study is to determine the primary resistance of H. pylori to antibiotics in Slovenia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Slovenian Society for Gastroenterology and Hepatology
• Collaborator: KRKA
• Treatments: Amoxicillin; Bismuth; Bismuth tripotassium dicitrate; Clarithromycin; Esomeprazole; Levofloxacin; Metronidazole; Ofloxacin

Criteria

Inclusion criteria:

• Patients 18 to 80 years of age.

• Patients have not received proton pump inhibitors for the past 14 days.

• Patients did not receive antibiotics in the last month.

• Helicobacter pylori infection has been demonstrated by rapid urease test.

Exclusion Criteria:

• Prior treatment for Helicobacter pylori infection (in patients who will receive Schedule 1 eradication therapy).•

• Defects in blood clotting. taking anticoagulant medicines that make it impossible to take biopsies.

• Allergy to drugs used in the study.

• Pregnancy, breastfeeding shold be excluded.

• Psychiatric illness that would prevent research participation.

• Active treatment for malignancy.