Recurrent Urinary Tract InfectionsNCT00678028
Association Between Deficiency of MBL (Mannose-Binding Lectin) and Polymorphisms in MBL2 Gene to Urinary Tract Infection
An observational study of Recurrent Urinary Tract Infections, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Due to genetic polymorphism about 15%-30% of the world population have low levels of MBL (Mannose Binding Lectin) in serum (below 500ng/mL). Different studies reported correlation between polymorphism in the MBL gene with low levels of MBL in serum and higher frequency of recurrent infections, severity of sepsis, ARDS… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Urinary Tract Infections
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2008to not given
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: young women with recurrent UTI - study group and young women witout recurrent UTI - a control group
Who may be able to join
- women above 18 years old.
- premenopausal
- recurrent UTI
Who cannot join
- pregnancy
- immunocompromised
- active malignancy
- HIV carrier
Trial locations and contacts
1 site in 1 country.
About this study
Due to genetic polymorphism about 15%-30% of the world population have low levels of MBL (Mannose Binding Lectin) in serum (below 500ng/mL). Different studies reported correlation between polymorphism in the MBL gene with low levels of MBL in serum and higher frequency of recurrent infections, severity of sepsis, ARDS and other infections. Urinary Tract Infection (UTI) is one of the very common infection in women. Since MBL is part of the innate immunity and there are proofs of relation between patients with recurrent infections and lack of MBL, we decided to explore a possible relation between low levels of MBL and different genotypes of MBL in young women and the risk to develop recurrent UTI.
- Conditions
- Recurrent Urinary Tract Infections
- Keywords
- MBL, UTI
- Medical subject headings
- Urinary Tract Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionsStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678028
- Sponsor's protocol ID
- 0080-07-EMC
- Status last verified
- Apr 2009
- First submitted
- 17 Feb 2008
- Last updated
- 23 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Deficiency of MBL (Mannose-Binding Lectin) and Polymorphisms in MBL2 Gene to Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT00678028
- Acronym / sponsor ID
- 0080-07-EMC
- Conditions
- Recurrent Urinary Tract Infections
- Keywords
- MBL, UTI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Feb 2008
- First posted
- 15 May 2008 (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.
Due to genetic polymorphism about 15%-30% of the world population have low levels of MBL (Mannose Binding Lectin) in serum (below 500ng/mL). Different studies reported correlation between polymorphism in the MBL gene with low levels of MBL in serum and higher frequency of recurrent infections, severity of sepsis, ARDS and other infections. Urinary Tract Infection (UTI) is one of the very common infection in women. Since MBL is part of the innate immunity and there are proofs of relation between patients with recurrent infections and lack of MBL, we decided to explore a possible relation between low levels of MBL and different genotypes of MBL in young women and the risk to develop recurrent UTI.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- young women with recurrent UTI - study group and young women witout recurrent UTI - a control group
Key inclusion criteria (3 listed)
- women above 18 years old.
- premenopausal
- recurrent UTI
Key exclusion criteria (4 listed)
- pregnancy
- immunocompromised
- active malignancy
- HIV carrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 23 Apr 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Recurrent Urinary Tract Infections, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 3 inclusion and 4 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 23 Apr 2009. 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 Israel. 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.
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 23 Apr 2009.