Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503048
Status:
COMPLETED
Last Update Posted:
2008-12-25
First Post:
2007-07-17
Brief Title:
Markers of Atopy in Children With Presumed Early Exposure to Allergens Unhygienic Conditions and Infections
Sponsor:
Medical University of Lodz
Organization:
Medical University of Lodz
Study Overview
Official Title:
Markers of Atopy in Children With Presumed Early Exposure to Allergens Unhygienic Conditions and Infections
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None