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 range

18 Years – 80 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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