The Role of Cathepsin X in Infection With the Helicobacter Pylori

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.

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.

Study Overview

• Status: Unknown
• Conditions: Persistence of Infection With Helicobacter Pylori
• Intervention / Treatment: Drug: clarithromycin, metronidazole, proton pump inhibitor

• Study Type: Observational
• Enrollment (Anticipated): 14

Contacts and Locations

Study Locations

• Slovenia
  • Rogaska Slatina, Slovenia
    • Recruiting
    • Abakus Medico
    • Contact: Bojan Tepes, MD. PhD; Phone Number: +386 (0) 3 819 14 11; Email: abakus.medico@volja.net
    • Principal Investigator: Bojan Tepes, MD, Phd
    • Sub-Investigator: Miha Skvarc, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	7 months after last participant included in the study

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Investigators: Study Director: Alojz Ihan, MD, PhD, Institute of microbiology and immunology, Ljubljana, Slovenia

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Anticipated): July 1, 2010

Study Registration Dates

• First Submitted: June 2, 2010
• First Submitted That Met QC Criteria: June 4, 2010
• First Posted (Estimate): June 7, 2010

Study Record Updates

• Last Update Posted (Estimate): July 12, 2010
• Last Update Submitted That Met QC Criteria: July 9, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: helicobacter pylori; eradication failure
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Clarithromycin; Proton Pump Inhibitors
• Other Study ID Numbers: IMI2010-1; 1000-05-310123 (Other Grant/Funding Number: Slovenian Research Agency (ARRS))