The Role of Cathepsin X in Infection With the Helicobacter Pylori
Recruitment status was Recruiting
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| First Received Date ICMJE | June 2, 2010 | ||||||||
| Last Updated Date | July 9, 2010 | ||||||||
| Start Date ICMJE | November 2008 | ||||||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Evidence that cathepsin X influences on the eradication of Helicobacter pylori confirmed by lower expression of cathepsin X and cytokines in those patients. that can not eradicate Helicobacter pylori. [ Time Frame: 7 months after last participant included in the study ] [ Designated as safety issue: No ] The investigators assume that vast majority of patients, that have problems with eradication of Helicobater pylori, not caused by primary resistence to antibiotics, can not eradicate helicobacter because of inappropriate immune response. The investigators will measure cathepsin X (CTSX) expression and assume that those patients who have low concentrations of CTSX also have inappropriate immune response seen in low levels of cytokines. To treat such patients, you need to give them different and longer antibiotic therapy. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01137942 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Role of Cathepsin X in Infection With the Helicobacter Pylori | ||||||||
| Official Title ICMJE | Helicobacter Pylori and Gastric Cancer - the Role of Cytokine Polymorphism, Cytokine Expression and Expression of TLR on Persistence of Helicobacter Pylori Infection and Development of Gastric Cancer. | ||||||||
| Brief Summary | The immune response to Helicobacter pylori (Hp) importantly determines the pathogenesis of infection as well as the success of antibiotic eradication of the bacteria. The investigators want to demonstrate the importance of cathepsin X (CTSX), a cysteine protease, for the Hp eradication success. The diversity of the innate immune response to H. pylori antigens leading to either successful eradication of the infection or maintenance of chronic inflammation is connected to CTSX. The aim of this study is to determine whether H. pylori suppresses the CTSX expression and cytokine secretion in macrophage cell line THP-1 in the individuals that are not capable of eradicating the infection, opposite to H pylori in patients with successful H pylori eradication . The investigators also investigate the possibility whether strain-dependent differences in H. pylori lipopolysaccharide (LPS) influence the CTSX expression and cytokine secretion. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Helicobacter pylori strains from patients are stored at -70oC. |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | The investigators invited people who had problems with H. pylori(Hp) infection. They were tested for Hp and if positive they were enrolled in the study.All patients were treated with appropriate therapy.3 months after antibiotic therapy, the patients were re-examined. The patients that had a positive test were invited to another re-evaluation.If H. pylori sensitive to all antibiotics tested was isolated, we enrolled the patient in the study-7 patients. The investigators took the patient's first isolate and used it to prepare antigens for the study. All patients in the control group, 7 patients, were successfully cured with first attempt of antimicrobial therapy.Seven months after last patient enrolled, all the participants will be re-evaluated to see if they are still infected with Hp. |
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| Condition ICMJE | Persistence of Infection With Helicobacter Pylori | ||||||||
| Intervention ICMJE | Drug: clarithromycin, metronidazole, proton pump inhibitor
appropriate dose of antibiotics and proton pump inhibitor
Other Name: No other names |
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| Study Group/Cohort (s) | H. pylori eradication failure
Those who eradicated Helicobacter pylori with appropriate antibiotic therapy and those who did not.
Intervention: Drug: clarithromycin, metronidazole, proton pump inhibitor |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 14 | ||||||||
| Estimated Completion Date | July 2010 | ||||||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:People with helicobacter gastritis and Helicobacter sensitive to antibiotic therapy but failure of therapy - Exclusion Criteria:People with helicobacter gastritis who did not eradicate Helicobacter pylori because of primary resistance to antibiotics. - |
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Slovenia | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01137942 | ||||||||
| Other Study ID Numbers ICMJE | IMI2010-1, 1000-05-310123 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Srecko Koren, Institute of microbiology and immunology, Medical faculty Ljubljana, Slovenia | ||||||||
| Study Sponsor ICMJE | University Medical Centre Ljubljana | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Medical Centre Ljubljana | ||||||||
| Verification Date | March 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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