Vilnius University Hospital Santaros Clinics
Vilnius, Lithuania
NCT Number: NCT05287074
The aim of this study is to gain more knowledge on the nutritional and immunological aspects of allergy to milk and eggs in children.
Interested in participating?
Request Info6 month–12 year
All sexes
Observational
Vilnius, Lithuania
Food allergy in children is an emerging problem in many countries. Milk and eggs are important sources of nutrition in childhood. Restricting these products in children's diets can affect the quality of child's life and nutrition, which is paramount to good physical and mental child development during this vulnerable period of life. The aim of this study is to gain more knowledge on the nutritional and immunological aspects of immunoglobulin E (IgE) mediated allergy to milk and eggs in children. In this study we will analyze parent perceived child's quality of life, factual nutrition (assessed by 3-day food diaries), food allergy self efficacy measure for parents, parent perceived quality of life will be assessed using Food Allergy Quality of Life Questionnaire - Parent Form, anthropometric measures of children (height and weight), serum nutritional markers (vitamin D, calcium, magnesium, iron and phosphorous), sensitization tests (specific Immunoglobulin E (sIgE) to milk and egg and their components) as well as markers of allergic inflammation (interleukin 10, 13, 17, 25 and 33, eosinophil count and serum Immunoglobulin E). Food allergy will be confirmed by an oral food challenge (OFC), variables will be compared between different OFC outcomes (sensitized-allergic/sensitized-non-allergic).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Within one month of enrolment.
Dietary intake will be assessed by a 3-day food diary, the nutrient intake will be analyzed using national food composition database and a nutritional analysis software.
Time frame: Within one day of enrolment.
Anthropometric measurements (weight and height) will be recorded and evaluated as Z-scores using the WHO ANTHRO program and WHO ANTHRO Plus Software.
Time frame: Within one month of enrollment
Parental confidence will be assessed using Food Allergy Self-Efficacy Scale for Parents (FASE-P), (scale of 0 to 100).
Time frame: Within one month of enrollment
Parent perceived quality of life will be assessed using Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF), (scale of 0 to 6).
Time frame: Within one month of enrollment
Prick to Prick test with cow's milk mean value.
Time frame: Within one month of enrollment
Prick to Prick test with hen's egg mean value.
Time frame: Within one month of enrollment
Measurement of serum total IgE.
Time frame: Within one month of enrollment
Measurement of serum eosinophils
Time frame: Within one month of enrollment
Measurement of serum specific IgE to milk extract.
Time frame: Within one month of enrollment
Measurement of serum specific IgE to egg extract.
Time frame: Within one month of enrollment
Measurement of serum specific IgE to casein.
Time frame: Within one month of enrollment
Measurement of serum specific IgE to betalactoglobulin.
Time frame: Within one month of enrollment
Measurement of serum specific IgE to ovomucoid.
Time frame: Within one month of enrollment
Measurement of serum specific IgE to ovalbumin.
Time frame: Within one month of enrollment
Laboratory measurement of vitamin D concentration.
Time frame: Within one month of enrollment
Laboratory measurement of serum calcium concentration.
Time frame: Within one month of enrollment
Laboratory measurement of serum phosphorus concentration.
Time frame: Within one month of enrollment
Laboratory measurement of serum iron concentration.
Time frame: Within one month of enrollment
Laboratory measurement of serum magnesium concentration.
Time frame: Within one month of enrollment
Laboratory measurement of serum interleukin 25.
Time frame: Within one month of enrollment
Laboratory measurement of serum interleukin 33.
Time frame: Within one month of enrollment
Laboratory measurement of serum interleukin 17.
Time frame: Within one month of enrollment
Laboratory measurement of serum interleukin 13.
Time frame: Within one month of enrollment
Laboratory measurement of serum interleukin 10.
Vilnius University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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