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Enrolling by Invitation

NCT Number: NCT05287074

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.

Enrolling by Invitation

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Key information

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vilnius University Hospital Santaros Clinics

Vilnius, Lithuania

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Evaluation of the daily food intake of children following egg and/or milk elimination diets.

    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.

  2. Antropometric measurements - Z-scores

    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.

Secondary outcomes

  1. Evaluation of parental confidence in managing food allergy.

    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).

  2. Evaluation of the parent perceived quality of life of children following egg and/or milk elimination diets.

    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).

Other outcomes

  1. Prick to Prick test with cow's milk mean value.

    Time frame: Within one month of enrollment

    Prick to Prick test with cow's milk mean value.

  2. Prick to Prick test with hen's egg mean value.

    Time frame: Within one month of enrollment

    Prick to Prick test with hen's egg mean value.

  3. Measurement of serum total IgE.

    Time frame: Within one month of enrollment

    Measurement of serum total IgE.

  4. Measurement of serum eosinophils.

    Time frame: Within one month of enrollment

    Measurement of serum eosinophils

  5. Measurement of serum specific IgE to milk extract.

    Time frame: Within one month of enrollment

    Measurement of serum specific IgE to milk extract.

  6. Measurement of serum specific IgE to egg extract.

    Time frame: Within one month of enrollment

    Measurement of serum specific IgE to egg extract.

  7. Measurement of serum specific IgE to casein.

    Time frame: Within one month of enrollment

    Measurement of serum specific IgE to casein.

  8. Measurement of serum specific IgE to betalactoglobulin.

    Time frame: Within one month of enrollment

    Measurement of serum specific IgE to betalactoglobulin.

  9. Measurement of serum specific IgE to ovomucoid.

    Time frame: Within one month of enrollment

    Measurement of serum specific IgE to ovomucoid.

  10. Measurement of serum specific IgE to ovalbumin.

    Time frame: Within one month of enrollment

    Measurement of serum specific IgE to ovalbumin.

  11. Laboratory measurement of vitamin D concentration.

    Time frame: Within one month of enrollment

    Laboratory measurement of vitamin D concentration.

  12. Laboratory measurement of serum calcium concentration.

    Time frame: Within one month of enrollment

    Laboratory measurement of serum calcium concentration.

  13. Laboratory measurement of serum phosphorus concentration.

    Time frame: Within one month of enrollment

    Laboratory measurement of serum phosphorus concentration.

  14. Laboratory measurement of serum iron concentration.

    Time frame: Within one month of enrollment

    Laboratory measurement of serum iron concentration.

  15. Laboratory measurement of serum magnesium concentration.

    Time frame: Within one month of enrollment

    Laboratory measurement of serum magnesium concentration.

  16. Laboratory measurement of serum interleukin 25.

    Time frame: Within one month of enrollment

    Laboratory measurement of serum interleukin 25.

  17. Laboratory measurement of serum interleukin 33.

    Time frame: Within one month of enrollment

    Laboratory measurement of serum interleukin 33.

  18. Laboratory measurement of serum interleukin 17.

    Time frame: Within one month of enrollment

    Laboratory measurement of serum interleukin 17.

  19. Laboratory measurement of serum interleukin 13.

    Time frame: Within one month of enrollment

    Laboratory measurement of serum interleukin 13.

  20. Laboratory measurement of serum interleukin 10.

    Time frame: Within one month of enrollment

    Laboratory measurement of serum interleukin 10.

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
Mar 18, 2022
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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