Markers of Atopy in Children With Presumed Early Exposure to Allergens, Unhygienic Conditions, and Infections

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00503048
First received: July 17, 2007
Last updated: December 23, 2008
Last verified: December 2008

July 17, 2007
December 23, 2008
December 2003
October 2007   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00503048 on ClinicalTrials.gov Archive Site
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Markers of Atopy in Children With Presumed Early Exposure to Allergens, Unhygienic Conditions, and Infections
Markers of Atopy in Children With Presumed Early Exposure to Allergens, Unhygienic Conditions, and Infections

There are many studies regarding possible causes of increasing trend in frequency of allergic diseases in the last three decades. Main causes of this trend are: decrease of infectious diseases frequency, improvement in life level, changes in diet and lactic acid bacterias elimination from digestive tract. Primary Purpose of this study is to compare the prevalence of atopy and atopic diseases in two child populations: foster care and reference children and - to define risk and protective factors for the development of atopy.

There are many studies regarding possible causes of increasing trend in frequency of allergic diseases in the last three decades. Main causes of this trend are: decrease of infectious diseases frequency, improvement in life level, changes in diet and lactic acid bacterias elimination from digestive tract. Less exposition to microbes can lead to the disturbance in optimal balance between Th1 and Th2 lymphocytes, prevalence of Th2 cytokines and excessively high production of IgE. Decreased exposure to microbes has resulted in the loss of main source of immune provocation, and a consequent increase in pathogenic immune responses and their associated diseases. Molecular interactions between immunocytes and microbes are mediated largely by Toll-like receptors (TLRs) on host cells and a diversity of ligands produced by viruses, bacteria and fungi.

Many studies confirm the protective role of some viral, bacterial or parasite infections against atopy development.

The studied group consisted of 500 children, living in all the ten community foster homes in Lodz. The reference group consisted of 500 children, living with their parents at home, recruited from primary care centres.

Primary Purpose of this study is to compare the prevalence of atopy and atopic diseases in two child populations: foster care and reference children and - to define risk and protective factors for the development of atopy.

Secondary Purpose is the genotyping and cytometric study - to define risk and protective factors for the development of atopy.

Primary outcome measures: skin prick test results with 18 allergens, peripheral blood eosinophil count, level of total and specific IgE in children with positive skin-test results were secondary and point, spirometry, medical history and physical examination.

Secondary outcome measures: included symptoms of asthma and other allergic diseases, lung function, parental allergy only for children from reference group, family history including life conditions in very early childhood, and markers of allergy such as total IgE serum concentration and eosinophil blood count, expression of TLR2, TLR4, TLR7, TLR9, examining the serum samples for specific antibodies to Toxocara sp, Toxoplasma gondi, Ascaris lumbricoides, DNA.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood samples

Non-Probability Sample

Children.

Atopic Diseases
Not Provided
  • 1
    foster care children
  • 2
    reference children (living with families)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
915
November 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • must be able to make spirometry

Exclusion Criteria:

  • pregnancy
Both
5 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00503048
RNN-268-03-KE
Yes
Iwona Stelmach MD, PhD, Prof, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Medical Universtity of Lodz
Ministry of Science and Higher Education, Poland
Principal Investigator: Katarzyna Smejda, MD Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Study Chair: Iwona Stelmach, MD, PhD, Prof Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Medical Universtity of Lodz
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP