The Role of Cathepsin X in Infection With the Helicobacter Pylori

• Conditions: Persistence of Infection With Helicobacter Pylori
• Interventions: Drug: clarithromycin, metronidazole, proton pump inhibitor

• Registration Number: NCT01137942
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-12
• Status Verified: 2010-03
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Study Completion: 2010-07
• Last Update Submitted: 2010-07-09
• Last Update Posted: 2010-07-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
H. pylori eradication failure	clarithromycin, metronidazole, proton pump inhibitor	Those who eradicated Helicobacter pylori with appropriate antibiotic therapy and those who did not.

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Abakus Medico; 🇸🇮 Rogaska Slatina, Slovenia