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

• Conditions: Urinary Tract Infection

• Registration Number: NCT02021305
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-12
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-20
• Last Update Submitted: 2013-12-20
• Study First Posted: 2013-12-27
• Last Update Posted: 2013-12-27
• Primary Completion: 2014-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	4 years

Trial Locations

Locations (1)

Aristotle University of Thessaloniki; 🇬🇷 Thessaloniki, Greece