H. Pylori Eradication Failure Clinical Trial
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
| Verified date | July 2010 |
| Source | University Medical Centre Ljubljana |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Slovenia: Ministry of Health |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | July 2010 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Slovenia | Institute of microbiology and immunology | Ljubljana |
| Lead Sponsor | Collaborator |
|---|---|
| University Medical Centre Ljubljana | Institute of microbiology and immunology, Slovenia |
Slovenia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No |
| Primary | 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. | No |