Clinical trial NCT02021305: The Role of TLR-4 Polymorphisms in Children With Urinary Track Infections
Official title: The Role of TLR-4 Asp299Gly and Thr399Ile Polymorphisms in Children With Urinary Tack Infections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Tract Infection
Keywords: Toll like Receptors
TLR 4
Urinary track infections in children
TLR 4 polymorphisms
Innate immunity
Defence mechanisms
Immune responses
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients an controls are selected from the Emergency Department and Outpatient Clinics of the 4th Department of Pediatrics , Aristotle University of Thessaloniki, Papageorgiou Hospital, Thessaloniki, Greece

Brief summary: 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: 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.

Eligibility criteria: 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

Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: frequency of TLR-4 299, 399 polymorphism and expression of TLR-2 and TLR-4 by monocytes in children with urinary track infection and healthy controls.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Efimia Papadopoulou-Alataki, MD, PhD
role: STUDY_DIRECTOR
References: