- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00503048
Markers of Atopy in Children With Presumed Early Exposure to Allergens, Unhygienic Conditions, and Infections
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lodz, Poland, 93-513
- Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- must be able to make spirometry
Exclusion Criteria:
- pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
foster care children
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2
reference children (living with families)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Iwona Stelmach, MD, PhD, Prof, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
- Principal Investigator: Katarzyna Smejda, MD, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNN-268-03-KE
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