The Role of Cathepsin X in Infection With the Helicobacter Pylori
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Persistence of Infection With Helicobacter Pylori |
Drug: clarithromycin, metronidazole, proton pump inhibitor |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | 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. |
- 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.
Biospecimen Retention: Samples With DNA
Helicobacter pylori strains from patients are stored at -70oC.
| Estimated Enrollment: | 14 |
| Study Start Date: | November 2008 |
| Estimated 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
Those who eradicated Helicobacter pylori with appropriate antibiotic therapy and those who did not.
|
Drug: clarithromycin, metronidazole, proton pump inhibitor
appropriate dose of antibiotics and proton pump inhibitor
Other Name: No other names
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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.
-
Contacts and Locations| Contact: Alojz Ihan, MD, PhD | 0038615437493 | alojz.ihan@mf.uni-lj.si |
| Contact: Miha Skvarc, MD | 0038615437484 | miha.skvarc@mf.uni-lj.si |
| Slovenia | |
| Abakus Medico | Recruiting |
| Rogaska Slatina, Slovenia | |
| Contact: Bojan Tepes, MD. PhD +386 (0) 3 819 14 11 abakus.medico@volja.net | |
| Principal Investigator: Bojan Tepes, MD, Phd | |
| Sub-Investigator: Miha Skvarc, MD | |
| Study Director: | Alojz Ihan, MD, PhD | Institute of microbiology and immunology, Ljubljana, Slovenia |
More Information
No publications provided
| Responsible Party: | Srecko Koren, Institute of microbiology and immunology, Medical faculty Ljubljana, Slovenia |
| ClinicalTrials.gov Identifier: | NCT01137942 History of Changes |
| Other Study ID Numbers: | IMI2010-1, 1000-05-310123 |
| Study First Received: | June 2, 2010 |
| Last Updated: | July 9, 2010 |
| Health Authority: | Slovenia: Ethics Committee |
Keywords provided by University Medical Centre Ljubljana:
|
helicobacter pylori eradication failure |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Metronidazole Clarithromycin Proton Pump Inhibitors |
Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 19, 2013