Atopic Diseases Clinical Trial
Official title:
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.
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Observational Model: Cohort, Time Perspective: Retrospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03489733 -
Prevention of Allergic Diseases in Infants
|
N/A |