Clinical trial NCT05287074: The Significance of a Timely Food Allergy Diagnosis and Optimal Surveillance of Nutritional Status in Children
Official title: The Significance of a Timely Food Allergy Diagnosis and Optimal Surveillance of Nutritional Status in Children
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Food Allergy in Children
Food Allergy in Infants
Keywords: Food allergy
Milk
Egg
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects from 6 months to 12 years of age with suspected or confirmed allergy to chicken's egg and/or cow's milk, referred for an oral food challenge with milk or egg will be enrolled.

Brief summary: The aim of this study is to gain more knowledge on the nutritional and immunological aspects of allergy to milk and eggs in children.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Subjects from 6 months to 12 years of age and their parents / guardians.
* Subjects with suspected or confirmed allergy to chicken's egg and/or cow's milk. Suspected food allergy is defined as sensitization to a food that has not been consumed recently (in the last 3 months) without symptoms or sensitization to a food that has never been consumed. A confirmed food allergy is defined as a food allergy that has previously been confirmed by a positive result of an oral food challenge.
* Legal guardians of the subject are capable to sign a written informed consent form.

Exclusion Criteria:

* Subjects to whom food allergies are unlikely (who have recently eaten a suspected food without symptoms or who have not eaten food recently but have never had symptoms and are not sensitized).
* Subjects to whom an oral food challenge is contraindicated.
* Subjects with comorbid chronic diseases affecting the child 's nutrition and growth.
* Legal guardians of the subject do not wish to participate in the study or are unable to sign a written consent form.

Primary outcomes:
measure: Evaluation of the daily food intake of children following egg and/or milk elimination diets.
timeFrame: Within one month of enrolment.
measure: Antropometric measurements - Z-scores
timeFrame: Within one day of enrolment.
Secondary outcomes:
measure: Evaluation of parental confidence in managing food allergy.
timeFrame: Within one month of enrollment
measure: Evaluation of the parent perceived quality of life of children following egg and/or milk elimination diets.
timeFrame: Within one month of enrollment
Other outcomes:
measure: Prick to Prick test with cow's milk mean value.
timeFrame: Within one month of enrollment
measure: Prick to Prick test with hen's egg mean value.
timeFrame: Within one month of enrollment
measure: Measurement of serum total IgE.
timeFrame: Within one month of enrollment
measure: Measurement of serum eosinophils.
timeFrame: Within one month of enrollment
measure: Measurement of serum specific IgE to milk extract.
timeFrame: Within one month of enrollment
measure: Measurement of serum specific IgE to egg extract.
timeFrame: Within one month of enrollment
measure: Measurement of serum specific IgE to casein.
timeFrame: Within one month of enrollment
measure: Measurement of serum specific IgE to betalactoglobulin.
timeFrame: Within one month of enrollment
measure: Measurement of serum specific IgE to ovomucoid.
timeFrame: Within one month of enrollment
measure: Measurement of serum specific IgE to ovalbumin.
timeFrame: Within one month of enrollment
measure: Laboratory measurement of vitamin D concentration.
timeFrame: Within one month of enrollment
measure: Laboratory measurement of serum calcium concentration.
timeFrame: Within one month of enrollment
measure: Laboratory measurement of serum phosphorus concentration.
timeFrame: Within one month of enrollment
measure: Laboratory measurement of serum iron concentration.
timeFrame: Within one month of enrollment
measure: Laboratory measurement of serum magnesium concentration.
timeFrame: Within one month of enrollment
measure: Laboratory measurement of serum interleukin 25.
timeFrame: Within one month of enrollment
measure: Laboratory measurement of serum interleukin 33.
timeFrame: Within one month of enrollment
measure: Laboratory measurement of serum interleukin 17.
timeFrame: Within one month of enrollment
measure: Laboratory measurement of serum interleukin 13.
timeFrame: Within one month of enrollment
measure: Laboratory measurement of serum interleukin 10.
timeFrame: Within one month of enrollment
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Clinics
Study officials:
affiliation: Vilnius University Faculty of Medicine
name: Ieva Adomaite, MD
role: PRINCIPAL_INVESTIGATOR
References: