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CompletedNCT00503048Updated Dec 25, 2008

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

An observational study in Atopic Diseases, sponsored by Medical University of Lodz. Completed at 1 site in Poland. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-12-25.

Sponsored by Medical University of Lodz · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
915
Ages
5 Years to 18 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Atopic Diseases

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Keywords

  • atopy
  • atopic diseases
  • children
  • orphanages
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 915 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Medical University of Lodz is the lead sponsor of 101 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children.

Inclusion criteria

  • must be able to make spirometry

Exclusion criteria

Exclusion Criteria:

  • pregnancy
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
915 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    foster care children

  • 2

    reference children (living with families)

06

Study locations

1 site
  • Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
    Lodz, 93-513, Poland
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References and documents

Publications

  • 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. PubMed 16875155 ↗
  • 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. PubMed 17718105 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00503048
Lead sponsor
Medical University of Lodz
Collaborators
Ministry of Science and Higher Education, Poland
First posted
Jul 18, 2007
Start date
Dec 2003
Primary completion
Oct 2007
Completion
Nov 2007
Last update
Dec 25, 2008

Study contacts

Katarzyna Smejda, MD
principal investigator · Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Iwona Stelmach, MD, PhD, Prof
study chair · Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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