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

Food Allergy in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05287074
• Other study ID #: MAMS2018
• Status: Enrolling by invitation
• Start date: July 1, 2021
• Est. completion date: June 1, 2028

Study information

• Verified date: July 2021
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: June 1, 2028
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Food Allergy in Children
• Food Allergy in Infants
• Food Hypersensitivity
• Hypersensitivity

Locations

Country	Name	City	State
Lithuania	Vilnius University Hospital Santaros Clinics	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Measurement of serum total IgE.	Measurement of serum total IgE.	Within one month of enrollment
Other	Measurement of serum eosinophils.	Measurement of serum eosinophils	Within one month of enrollment
Other	Measurement of serum specific IgE to milk extract.	Measurement of serum specific IgE to milk extract.	Within one month of enrollment
Other	Measurement of serum specific IgE to egg extract.	Measurement of serum specific IgE to egg extract.	Within one month of enrollment
Other	Measurement of serum specific IgE to casein.	Measurement of serum specific IgE to casein.	Within one month of enrollment
Other	Measurement of serum specific IgE to betalactoglobulin.	Measurement of serum specific IgE to betalactoglobulin.	Within one month of enrollment
Other	Measurement of serum specific IgE to ovomucoid.	Measurement of serum specific IgE to ovomucoid.	Within one month of enrollment
Other	Measurement of serum specific IgE to ovalbumin.	Measurement of serum specific IgE to ovalbumin.	Within one month of enrollment
Other	Laboratory measurement of vitamin D concentration.	Laboratory measurement of vitamin D concentration.	Within one month of enrollment
Other	Laboratory measurement of serum calcium concentration.	Laboratory measurement of serum calcium concentration.	Within one month of enrollment
Other	Laboratory measurement of serum phosphorus concentration.	Laboratory measurement of serum phosphorus concentration.	Within one month of enrollment
Other	Laboratory measurement of serum iron concentration.	Laboratory measurement of serum iron concentration.	Within one month of enrollment
Other	Laboratory measurement of serum magnesium concentration.	Laboratory measurement of serum magnesium concentration.	Within one month of enrollment
Other	Laboratory measurement of serum interleukin 25.	Laboratory measurement of serum interleukin 25.	Within one month of enrollment
Other	Laboratory measurement of serum interleukin 33.	Laboratory measurement of serum interleukin 33.	Within one month of enrollment
Other	Laboratory measurement of serum interleukin 17.	Laboratory measurement of serum interleukin 17.	Within one month of enrollment
Other	Laboratory measurement of serum interleukin 13.	Laboratory measurement of serum interleukin 13.	Within one month of enrollment
Other	Laboratory measurement of serum interleukin 10.	Laboratory measurement of serum interleukin 10.	Within one month of enrollment
Primary	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.
Primary	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	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
Secondary	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