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

NCT ID: NCT00503048

Last Updated: 2008-12-25

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

COMPLETED

Total Enrollment

915 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-12-31

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atopic Diseases

Keywords

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atopy atopic diseases children orphanages

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

foster care children

No interventions assigned to this group

2

reference children (living with families)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* must be able to make spirometry

Exclusion Criteria

* pregnancy
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Science and Higher Education, Poland

OTHER_GOV

Sponsor Role collaborator

Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Principal Investigators

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Katarzyna Smejda, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Iwona Stelmach, MD, PhD, Prof

Role: STUDY_CHAIR

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Locations

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Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland

Lodz, , Poland

Site Status

Countries

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Poland

References

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Stelmach I, Smejda K, Kaczmarek J, Stelmach W, Kuna P. [Prevalence of atopy and atopic diseases in children living in an orphanage in Lodz area--pilot study]. Pol Merkur Lekarski. 2006 May;20(119):531-4. Polish.

Reference Type RESULT
PMID: 16875155 (View on PubMed)

Stelmach I, Smejda K, Jerzynska J, Stelmach W, Majak P, Stelmach P, Kuna P. Decreased markers of atopy in children with presumed early exposure to allergens, unhygienic conditions, and infections. Ann Allergy Asthma Immunol. 2007 Aug;99(2):170-7. doi: 10.1016/S1081-1206(10)60641-2.

Reference Type RESULT
PMID: 17718105 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/17718105?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

Article - Ann Allergy Asthma Immunol. 2007 Aug;99(2):170-7.

http://www.ncbi.nlm.nih.gov/pubmed/16875155?ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

Article - Pol Merkur Lekarski. 2006 May;20(119):531-4.

Other Identifiers

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RNN-268-03-KE

Identifier Type: -

Identifier Source: org_study_id