H. Pylori Eradication FailureNCT01164969
Mixed Strain H. Pylori Infection in Patients Who Have Problems With Eradication of H. Pylori
An observational study of H. Pylori Eradication Failure, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The purpose of this study is to determine whether mixed H. pylori strain infection is the reason for eradication failure during treatment of H. pylori infection. The investigators present the results got from extensive sampling of biopsy samples taken from individuals diagnosed with H. pylori connected disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- H. Pylori Eradication Failure
- What is being tested?
- Antibiotics to which H. pylori can not develope resistance
- How many people
- 10 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 were not able to eradicate H. pylori although at their first visit they had H. pylori sensitive to all antibiotics tested. At first visit all patients had stomach biopsy sample taken and H. pylori isolated and therapy prescribed. If they did not eradicate bacteria after 2 months they were again invited to control visit to define the problem and appropriate therapy prescribed. They were again invitation to control visit at the end of June 2010 to see the outcome of therapy.
Who may be able to join
- People who have H. pylori sensitive to all antibiotics before therapy and and do not eradicate H. pylori after appropriate antibiotic therapy.
Who cannot join
- People who did not eradicate H. pylori because of primary resistance to antibiotics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi Locus Sequence Typing (MLST) Used as Tool to Confirm Ability of Susceptible Helicobacter Pylori Strains to Gain Resistance to Clarithromycin During Eradication Therapy Independently of Mixed Strain Helicobacter Pylori Infection
The purpose of this study is to determine whether mixed H. pylori strain infection is the reason for eradication failure during treatment of H. pylori infection. The investigators present the results got from extensive sampling of biopsy samples taken from individuals diagnosed with H. pylori connected disease. The investigators were looking for individuals that were not able to eradicate H. pylori although they had susceptibility testing tailored antibiotic therapy. On their control visit after 2 months they presented again with H. pylori although at their first visit they had H. pylori isolated from biopsy sample sensitive to all antibiotics prescribed. Multi Locus Sequence Typing (MLST) was used to prove the sequence type of H. pylori and E test was used to determine susceptibility of H. pylori to antibiotics.
- Conditions
- H. Pylori Eradication Failure
- Being tested
- Antibiotics to which H. pylori can not develope resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotics to which H. pylori can not develope resistanceDrug
Amoxicillin, metronidazole and tetracyclin as primary drugs to treat H. pylori infection in duration of 10 days.
| Study group | Role | What they receive |
|---|---|---|
| H. pylori eradication failure | People who are not able to eradicate H. pylori although the appropriate antibiotic therapy taken. Receives: Drug: Antibiotics to which H. pylori can not develope resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori
The investigators assume that people that are not able to eradicate infection with H. pylori although they have never been treated for such infection and they have taken appropriate therapy, have such problems because H. pylori is capable to escape from immune response. The investigators will define if patients have the same H. pylori sequence type through longer period and that such H. pylori is capable to develope resistance to clarithromycin very quickly.Such patients can eliminate H. pylori if we check the infection status more often and give them more suitable antibiotic therapy.
Measured: Six months after first visit the strains from before/after therapy will be inspected with MLST to see if people have mixed strain infection.
Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori
The investigators assume that people that are not able to eradicate infection with H. pylori although they have never been treated for such infection and they have taken appropriate therapy, have such problems because H. pylori is capable to escape from immune response. The investigators will define if patients have the same H. pylori sequence type through longer period and that such H. pylori is capable to develope resistance to clarithromycin very quickly.Such patients can eliminate H. pylori if we check the infection status more often and give them more suitable antibiotic therapy.
Measured: 9 months after first visit to see if people still have H. pylori due to insufficient immune response.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startNov 2008
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H. Pylori Eradication FailureStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of microbiology and immunology, Slovenia
- Investigators
- Alojz Ihan, MD. PhD, Study director, Institute of mircobiology and immunology, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164969
- Sponsor's protocol ID
- IMI2010-2
- Status last verified
- Jul 2010
- First submitted
- 13 Jul 2010
- Last updated
- 19 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Locus Sequence Typing (MLST) Used as Tool to Confirm Ability of Susceptible Helicobacter Pylori Strains to Gain Resistance to Clarithromycin During Eradication Therapy Independently of Mixed Strain Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT01164969
- Acronym / sponsor ID
- IMI2010-2
- Conditions
- H. Pylori Eradication Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Institute of microbiology and immunology, Slovenia
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Jul 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 purpose of this study is to determine whether mixed H. pylori strain infection is the reason for eradication failure during treatment of H. pylori infection. The investigators present the results got from extensive sampling of biopsy samples taken from individuals diagnosed with H. pylori connected disease. The investigators were looking for individuals that were not able to eradicate H. pylori although they had susceptibility testing tailored antibiotic therapy. On their control visit after 2 months they presented again with H. pylori although at their first visit they had H. pylori isolated from biopsy sample sensitive to all antibiotics prescribed. Multi Locus Sequence Typing (MLST) was used to prove the sequence type of H. pylori and E test was used to determine susceptibility of H. pylori to antibiotics.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H. pylori eradication failure | – | Drug: Antibiotics to which H. pylori can not develope resistancePeople who are not able to eradicate H. pylori although the appropriate antibiotic therapy taken. |
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 were not able to eradicate H. pylori although at their first visit they had H. pylori sensitive to all antibiotics tested. At first visit all patients had stomach biopsy sample taken and H. pylori isolated and therapy prescribed. If they did not eradicate bacteria after 2 months they were again invited to control visit to define the problem and appropriate therapy prescribed. They were again invitation to control visit at the end of June 2010 to see the outcome of therapy.
Key inclusion criteria (1 listed)
- People who have H. pylori sensitive to all antibiotics before therapy and and do not eradicate H. pylori after appropriate antibiotic therapy.
Key exclusion criteria (1 listed)
- People who did not eradicate H. pylori because of primary resistance to antibiotics.
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 |
|---|---|---|
| Antibiotics to which H. pylori can not develope resistanceAmoxicillin, metronidazole and tetracyclin as primary drugs to treat H. pylori infection in duration of 10 days. | Drug | H. pylori eradication failure |
Primary outcome
Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori
Time frame: Six months after first visit the strains from before/after therapy will be inspected with MLST to see if people have mixed strain infection.
The investigators assume that people that are not able to eradicate infection with H. pylori although they have never been treated for such infection and they have taken appropriate therapy, have such problems because H. pylori is capable to escape from immune response. The investigators will define if patients have the same H. pylori sequence type through longer period and that such H. pylori is capable to develope resistance to clarithromycin very quickly.Such patients can eliminate H. pylori if we check the infection status more often and give them more suitable antibiotic therapy.
Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori
Time frame: 9 months after first visit to see if people still have H. pylori due to insufficient immune response.
The investigators assume that people that are not able to eradicate infection with H. pylori although they have never been treated for such infection and they have taken appropriate therapy, have such problems because H. pylori is capable to escape from immune response. The investigators will define if patients have the same H. pylori sequence type through longer period and that such H. pylori is capable to develope resistance to clarithromycin very quickly.Such patients can eliminate H. pylori if we check the infection status more often and give them more suitable antibiotic therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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 mircobiology and immunology, 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 H. Pylori Eradication Failure, 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori (time frame: Six months after first visit the strains from before/after therapy will be inspected with MLST to see if people have mixed strain infection.). The study lists 2 primary outcomes in all. 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 19 Jul 2010.