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The Role of TLR-4 Polymorphisms in Children With Urinary Track Infections

NCT ID: NCT02021305

Last Updated: 2013-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-02-28

Brief Summary

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Purpose So far anatomical abnormalities (mostly congenital) were, in the majority of the patients, associated with urinary track infections. In this study the researchers will try to investigate the role of TLRs as molecular interactions between bacterial virulence and host response.

TLRs are important mediators in the development of the natural immunity against bacteria. They recognize microbial pathogen associated molecular patterns and alert the host's immune system to the presence of invading microbes

Detailed Description

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The aim of his observational case-control study is to :

1. investigate if the expression of TLR2 and TLR4 mediate in the development of the natural immunity of the uroepithileal cells against bacteria.
2. evaluate the effect of the TLR-gene Asp299Gly and Thr399Ile polymorphisms on the development and clinical severity of urinary tract infections (UTI) in children.
3. determine the association of the expression of TLR-2 and TLR-4 and TLR-4 polymorphisms with the formation of renal scar in children.
4. investigate the expression of TLR-2 and TLR-4 and TLR-4 polymorphisms in healthy children and elaborate the results to the possible carriers of these polymorphisms.

Conditions

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Urinary Tract Infection

Keywords

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Toll like Receptors TLR 4 Urinary track infections in children TLR 4 polymorphisms Innate immunity Defence mechanisms Immune responses

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

60 children with a recorded episode of acute Urinary Track infection who attended 4th Department of Pediatrics of Medical School of Aristotle University of Thessaloniki.

No interventions assigned to this group

Controls

100 children with no history of Urinary Track Infection who attended 4th Department of Pediatrics of Medical School of Aristotle University of Thessaloniki.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* For the patients

* 6months -14 years of age
* unrelated male and female children with one episode of acute urinary track infection (positive urine culture and clinical symptoms )
* with/without anatomic genitourinary anomalies .
* children with upper UTI or children with lower UTI
* Sign written informed consent


For the controls

* 6 months-14 years of age
* age and gender matched with the patients
* unrelated male and female children with no recorded history of urinary track infection and negative urine cultures .
* Sign written informed consent

Exclusion Criteria

* For the patients

* Subjects who do not meet the criteria above
* Severe or chronic illness
* Symptoms of acute infection
* Immune deficiency or immune suppressor therapy
* Medication


For the controls

* Subjects who do not meet the criteria above
* Severe or chronic illness
* Symptoms of acute infection
* Immune deficiency or immune suppressor therapy
* Medication
Minimum Eligible Age

6 Months

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Panagiota Karananou

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Efimia Papadopoulou-Alataki, MD, PhD

Role: STUDY_DIRECTOR

Aristotle University Of Thessaloniki

Locations

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Aristotle University of Thessaloniki

Thessaloniki, Thessaloniki, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Efimia Papadopoulou-Alataki, MD, PhD

Role: CONTACT

Phone: +302313323901

Email: [email protected]

Panagiota Karananou, MD

Role: CONTACT

Phone: +302313323901

Email: [email protected]

Facility Contacts

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Efimia Papadopoulou-Alataki, MD, PhD

Role: primary

Panagiota Karananou, MD

Role: backup

Other Identifiers

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230283

Identifier Type: -

Identifier Source: org_study_id