Persistence of Infection With Helicobacter PyloriNCT01137942
The Role of Cathepsin X in Infection With the Helicobacter Pylori
An observational study of Persistence of Infection With Helicobacter Pylori, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persistence of Infection With Helicobacter Pylori
- What is being tested?
- clarithromycin, metronidazole, proton pump inhibitor
- How many people
- 14 participants
- Where
- 1 siteSlovenia
- Study dates
- Nov 2008to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
-
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
Abakus Medico
Rogaška Slatina
Bojan Tepes, MD. PhD, +386 (0) 3 819 14 11, abakus.medico@volja.net
Bojan Tepes, MD, Phd
About this study
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.
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.
- Being tested
- clarithromycin, metronidazole, proton pump inhibitor
- Keywords
- helicobacter pylori, eradication failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clarithromycin, metronidazole, proton pump inhibitorDrug
Also called No other names
appropriate dose of antibiotics and proton pump inhibitor
| Study group | Role | What they receive |
|---|---|---|
| H. pylori eradication failure | Those who eradicated Helicobacter pylori with appropriate antibiotic therapy and those who did not. Receives: Drug: clarithromycin, metronidazole, proton pump inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months after last participant included in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startNov 2008
- Primary completionDec 2009
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistence of Infection With Helicobacter PyloriStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Investigators
- Alojz Ihan, MD, PhD, Study director, Institute of microbiology and immunology, Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137942
- Sponsor's protocol ID
- IMI2010-1
- Other IDs
- 1000-05-310123
- Status last verified
- Mar 2010
- First submitted
- 2 Jun 2010
- Last updated
- 12 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01137942
- Acronym / sponsor ID
- IMI2010-1
- Keywords
- helicobacter pylori, eradication failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (estimated)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H. pylori eradication failure | – | Drug: clarithromycin, metronidazole, proton pump inhibitorThose who eradicated Helicobacter pylori with appropriate antibiotic therapy and those who did not. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clarithromycin, metronidazole, proton pump inhibitorAlso: No other namesappropriate dose of antibiotics and proton pump inhibitor | Drug | H. pylori eradication failure |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alojz Ihan, MD, PhD study director
Institute of microbiology and immunology, Ljubljana, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistence of Infection With Helicobacter Pylori, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alojz Ihan, MD, PhD (0038615437493, alojz.ihan@mf.uni-lj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2010.