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

Urinary Tract Infection Clinical Trial

— TLR-4  

Official title:

The Role of TLR-4 Asp299Gly and Thr399Ile Polymorphisms in Children With Urinary Tack Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02021305
• Other study ID #: 230283
• Status: Recruiting
• Phase: N/A
• First received: December 20, 2013
• Last updated: December 20, 2013
• Start date: February 2013
• Est. completion date: February 2017

Study information

• Verified date: December 2013
• Source: Aristotle University Of Thessaloniki
• Contact: Efimia Papadopoulou-Alataki, MD, PhD
• Phone: +302313323901
• Email: efiala[@]otenet.gr
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: February 2017
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 14 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
Greece	Aristotle University of Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No