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The Role of Cathepsin X in Infection With the Helicobacter Pylori

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01137942
Recruitment Status : Unknown
Verified March 2010 by University Medical Centre Ljubljana.
Recruitment status was:  Recruiting
First Posted : June 7, 2010
Last Update Posted : July 12, 2010
Information provided by:
University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment
Persistence of Infection With Helicobacter Pylori Drug: clarithromycin, metronidazole, proton pump inhibitor

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Study Type : Observational
Estimated Enrollment : 14 participants
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.
Study Start Date : November 2008
Actual Primary Completion Date : December 2009
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

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 Name: No other names

Primary Outcome Measures :
  1. 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 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01137942

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Contact: Alojz Ihan, MD, PhD 0038615437493
Contact: Miha Skvarc, MD 0038615437484

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Abakus Medico Recruiting
Rogaska Slatina, Slovenia
Contact: Bojan Tepes, MD. PhD    +386 (0) 3 819 14 11   
Principal Investigator: Bojan Tepes, MD, Phd         
Sub-Investigator: Miha Skvarc, MD         
Sponsors and Collaborators
University Medical Centre Ljubljana
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Study Director: Alojz Ihan, MD, PhD Institute of microbiology and immunology, Ljubljana, Slovenia

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Responsible Party: Srecko Koren, Institute of microbiology and immunology, Medical faculty Ljubljana, Slovenia Identifier: NCT01137942     History of Changes
Other Study ID Numbers: IMI2010-1
1000-05-310123 ( Other Grant/Funding Number: Slovenian Research Agency (ARRS) )
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: July 12, 2010
Last Verified: March 2010

Keywords provided by University Medical Centre Ljubljana:
helicobacter pylori
eradication failure

Additional relevant MeSH terms:
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Communicable Diseases
Proton Pump Inhibitors
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors