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

Completed

• Conditions: H. Pylori Eradication Failure
• Interventions: Drug: Antibiotics to which H. pylori can not develope resistance

• Registration Number: NCT01164969
• Lead Sponsor: University Medical Centre Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-12
• Status Verified: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-16
• Last Update Submitted: 2010-07-16
• Study First Posted: 2010-07-19
• Last Update Posted: 2010-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
H. pylori eradication failure	Antibiotics to which H. pylori can not develope resistance	People who are not able to eradicate H. pylori although the appropriate antibiotic therapy taken.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Institute of microbiology and immunology; 🇸🇮 Ljubljana, Slovenia