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

NCT05287074 | Enrolling By Invitation DMC

• 1 other identifier: MAMS2018
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy in Children; Food Allergy in Infants

Keywords

Food allergy; Milk; Egg

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Evaluation of parental confidence in managing food allergy.

  Within one month of enrollment

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

  Within one month of enrollment

Other Outcomes (20)

• 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.

  Within one month of enrollment

• Measurement of serum total IgE.

  Within one month of enrollment

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vilnius University: lead

Study Sites (1)

Vilnius University Hospital Santaros Clinics

Vilnius, Lithuania

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ieva Adomaite, MD

  Vilnius University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: March 18, 2022
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 18, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)