Clinical trial NCT01164969: Mixed Strain H. Pylori Infection in Patients Who Have Problems With Eradication of H. Pylori
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: H. Pylori Eradication Failure
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: Institute of microbiology and immunology, Slovenia
First posted: 2010-07-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators invited people who were not able to eradicate H. pylori although at their first visit they had H. pylori sensitive to all antibiotics tested. At first visit all patients had stomach biopsy sample taken and H. pylori isolated and therapy prescribed. If they did not eradicate bacteria after 2 months they were again invited to control visit to define the problem and appropriate therapy prescribed. They were again invitation to control visit at the end of June 2010 to see the outcome of therapy.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
measure: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Institute of microbiology and immunology
Study officials:
affiliation: Institute of mircobiology and immunology, Slovenia
name: Alojz Ihan, MD. PhD
role: STUDY_DIRECTOR
References: