UnknownNot Applicable

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

Slovenia560 participantsStarted 2020-05-10

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Success rate of first line therapy for Helicobacter pylori infection

Timeframe: 2 years

Success rate of second line therapy for Helicobacter pylori infection

Timeframe: 3 years

Trial details

NCT IDNCT04359966

SponsorSlovenian Society for Gastroenterology and Hepatology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-31

Contact for this trial

BOJAN TEPES

0038641325916 bojan.tepes@siol.net

View on ClinicalTrials.gov More Helicobacter Pylori Infection trials