The Significance of a Timely Food Allergy Diagnosis and Optimal Surveillance of Nutritional Status in Children

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Food Allergy in Children; Food Allergy in Infants

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).

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania
    • Vilnius University Hospital Santaros Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the daily food intake of children following egg and/or milk elimination diets.	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.	Within one month of enrolment.
Antropometric measurements - Z-scores	Anthropometric measurements (weight and height) will be recorded and evaluated as Z-scores using the WHO ANTHRO program and WHO ANTHRO Plus Software.	Within one day of enrolment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of parental confidence in managing food allergy.	Parental confidence will be assessed using Food Allergy Self-Efficacy Scale for Parents (FASE-P), (scale of 0 to 100).	Within one month of enrollment
Evaluation of the parent perceived quality of life of children following egg and/or milk elimination diets.	Parent perceived quality of life will be assessed using Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF), (scale of 0 to 6).	Within one month of enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prick to Prick test with cow's milk mean value.	Prick to Prick test with cow's milk mean value.	Within one month of enrollment
Prick to Prick test with hen's egg mean value.	Prick to Prick test with hen's egg mean value.	Within one month of enrollment
Measurement of serum total IgE.	Measurement of serum total IgE.	Within one month of enrollment
Measurement of serum eosinophils.	Measurement of serum eosinophils	Within one month of enrollment
Measurement of serum specific IgE to milk extract.	Measurement of serum specific IgE to milk extract.	Within one month of enrollment
Measurement of serum specific IgE to egg extract.	Measurement of serum specific IgE to egg extract.	Within one month of enrollment
Measurement of serum specific IgE to casein.	Measurement of serum specific IgE to casein.	Within one month of enrollment
Measurement of serum specific IgE to betalactoglobulin.	Measurement of serum specific IgE to betalactoglobulin.	Within one month of enrollment
Measurement of serum specific IgE to ovomucoid.	Measurement of serum specific IgE to ovomucoid.	Within one month of enrollment
Measurement of serum specific IgE to ovalbumin.	Measurement of serum specific IgE to ovalbumin.	Within one month of enrollment
Laboratory measurement of vitamin D concentration.	Laboratory measurement of vitamin D concentration.	Within one month of enrollment
Laboratory measurement of serum calcium concentration.	Laboratory measurement of serum calcium concentration.	Within one month of enrollment
Laboratory measurement of serum phosphorus concentration.	Laboratory measurement of serum phosphorus concentration.	Within one month of enrollment
Laboratory measurement of serum iron concentration.	Laboratory measurement of serum iron concentration.	Within one month of enrollment
Laboratory measurement of serum magnesium concentration.	Laboratory measurement of serum magnesium concentration.	Within one month of enrollment
Laboratory measurement of serum interleukin 25.	Laboratory measurement of serum interleukin 25.	Within one month of enrollment
Laboratory measurement of serum interleukin 33.	Laboratory measurement of serum interleukin 33.	Within one month of enrollment
Laboratory measurement of serum interleukin 17.	Laboratory measurement of serum interleukin 17.	Within one month of enrollment
Laboratory measurement of serum interleukin 13.	Laboratory measurement of serum interleukin 13.	Within one month of enrollment
Laboratory measurement of serum interleukin 10.	Laboratory measurement of serum interleukin 10.	Within one month of enrollment

Collaborators and Investigators

• Sponsor: Vilnius University
• Investigators: Principal Investigator: Ieva Adomaite, MD, Vilnius University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): June 1, 2028

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Food allergy; Milk; Egg
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: MAMS2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No