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

NCT01164969 | Completed DMC

• 1 other identifier: IMI2010-2
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

H. Pylori Eradication Failure

Outcome Measures

Primary Outcomes (2)

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

  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.

  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

  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.

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

Study Arms (1)

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

Interventions

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.

H. pylori eradication failure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• People who have H. pylori sensitive to all antibiotics before therapy and and do not eradicate H. pylori after appropriate antibiotic therapy.

You may not qualify if:

• People who did not eradicate H. pylori because of primary resistance to antibiotics.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Institute of microbiology and immunology, Slovenia: collaborator

Study Sites (1)

Institute of microbiology and immunology

Ljubljana, 1000, Slovenia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Isolated PBMC cell from patients, isolated H. pylori

Study Officials

• Alojz Ihan, MD. PhD

  Institute of mircobiology and immunology, Slovenia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 19, 2010
• Study Start: November 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: July 1, 2010
• Last Updated: July 19, 2010

Record last verified: 2010-07

Locations

SL (1)