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

This study has been completed.
Sponsor:
Collaborator:
Institute of microbiology and immunology, Slovenia
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01164969
First received: July 13, 2010
Last updated: July 16, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
H. Pylori Eradication Failure
Drug: Antibiotics to which H. pylori can not develope resistance

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Isolated PBMC cell from patients, isolated H. pylori


Enrollment: 10
Study Start Date: November 2008
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
H. pylori eradication failure
People who are not able to eradicate H. pylori although the appropriate antibiotic therapy taken.
Drug: Antibiotics to which H. pylori can not develope resistance
Amoxicillin, metronidazole and tetracyclin as primary drugs to treat H. pylori infection in duration of 10 days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01164969

Locations
Slovenia
Institute of microbiology and immunology
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Institute of microbiology and immunology, Slovenia
Investigators
Study Director: Alojz Ihan, MD. PhD Institute of mircobiology and immunology, Slovenia
  More Information

No publications provided

Responsible Party: Institute of microbiology and immunology, Slovenia
ClinicalTrials.gov Identifier: NCT01164969     History of Changes
Other Study ID Numbers: IMI2010-2
Study First Received: July 13, 2010
Last Updated: July 16, 2010
Health Authority: Slovenia: Ministry of Health

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 23, 2014