CompletedNot Applicable

Mixed Strain H. Pylori Infection in Patients Who Have Problems With Eradication of H. Pylori

Slovenia10 participantsStarted 2008-11

Plain-language summary

The purpose of this study is to determine whether mixed H. pylori strain infection is the reason for eradication failure during treatment of H. pylori infection. The investigators present the results got from extensive sampling of biopsy samples taken from individuals diagnosed with H. pylori connected disease. The investigators were looking for individuals that were not able to eradicate H. pylori although they had susceptibility testing tailored antibiotic therapy. On their control visit after 2 months they presented again with H. pylori although at their first visit they had H. pylori isolated from biopsy sample sensitive to all antibiotics prescribed. Multi Locus Sequence Typing (MLST) was used to prove the sequence type of H. pylori and E test was used to determine susceptibility of H. pylori to antibiotics.

Who can participate

Age range

18 Years – 65 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: * People who have H. pylori sensitive to all antibiotics before therapy and and do not eradicate H. pylori after appropriate antibiotic therapy. Exclusion Criteria: * People who did not eradicate H. pylori because of primary resistance to antibiotics.

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

Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori

Timeframe: Six months after first visit the strains from before/after therapy will be inspected with MLST to see if people have mixed strain infection.

Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori

Timeframe: 9 months after first visit to see if people still have H. pylori due to insufficient immune response.

Trial details

NCT IDNCT01164969

SponsorUniversity Medical Centre Ljubljana

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2009-12

View on ClinicalTrials.gov More H. Pylori Eradication Failure trials

Plain-language summary

Who can participate

Age range

18 Years – 65 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.

What they're measuring

Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori

Timeframe: Six months after first visit the strains from before/after therapy will be inspected with MLST to see if people have mixed strain infection.

Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori

Timeframe: 9 months after first visit to see if people still have H. pylori due to insufficient immune response.