Completed

NCT Number: NCT01164969

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

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.

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Key information

Conditions

H. Pylori Eradication Failure

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of microbiology and immunology

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antibiotics to which H. pylori can not develope resistance

Drug

Amoxicillin, metronidazole and tetracyclin as primary drugs to treat H. pylori infection in duration of 10 days.

Primary outcomes

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

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

The investigators assume that people that are not able to eradicate infection with H. pylori although they have never been treated for such infection and they have taken appropriate therapy, have such problems because H. pylori is capable to escape from immune response. The investigators will define if patients have the same H. pylori sequence type through longer period and that such H. pylori is capable to develope resistance to clarithromycin very quickly.Such patients can eliminate H. pylori if we check the infection status more often and give them more suitable antibiotic therapy.
Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori

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

The investigators assume that people that are not able to eradicate infection with H. pylori although they have never been treated for such infection and they have taken appropriate therapy, have such problems because H. pylori is capable to escape from immune response. The investigators will define if patients have the same H. pylori sequence type through longer period and that such H. pylori is capable to develope resistance to clarithromycin very quickly.Such patients can eliminate H. pylori if we check the infection status more often and give them more suitable antibiotic therapy.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

Institute of microbiology and immunology, Slovenia

Registry information

Official study title

Multi Locus Sequence Typing (MLST) Used as Tool to Confirm Ability of Susceptible Helicobacter Pylori Strains to Gain Resistance to Clarithromycin During Eradication Therapy Independently of Mixed Strain Helicobacter Pylori Infection

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2010
First posted: Jul 19, 2010
Registry last updated: Jul 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.