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

Обзор

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

Подробное описание

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).

Первичные конечные точки

• Evaluation of the daily food intake of children following egg and/or milk elimination diets. [Срок оценки: Within one month of enrolment.]
• Antropometric measurements - Z-scores [Срок оценки: Within one day of enrolment.]

Вторичные конечные точки (2)

• Evaluation of parental confidence in managing food allergy. [Срок оценки: Within one month of enrollment]
• Evaluation of the parent perceived quality of life of children following egg and/or milk elimination diets. [Срок оценки: Within one month of enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Литва · 1 центр

• Vilnius University Hospital Santaros Clinics — Vilnius

Идентификаторы

NCT: NCT05287074 · MAMS2018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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