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

March 9, 2022 updated by: Vilnius University
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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within one month of enrolment.
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.
Within one day of enrolment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Within one month of enrollment
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).
Within one month of enrollment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Within one month of enrollment
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.
Within one month of enrollment
Measurement of serum total IgE.
Time Frame: Within one month of enrollment
Measurement of serum total IgE.
Within one month of enrollment
Measurement of serum eosinophils.
Time Frame: Within one month of enrollment
Measurement of serum eosinophils
Within one month of enrollment
Measurement of serum specific IgE to milk extract.
Time Frame: Within one month of enrollment
Measurement of serum specific IgE to milk extract.
Within one month of enrollment
Measurement of serum specific IgE to egg extract.
Time Frame: Within one month of enrollment
Measurement of serum specific IgE to egg extract.
Within one month of enrollment
Measurement of serum specific IgE to casein.
Time Frame: Within one month of enrollment
Measurement of serum specific IgE to casein.
Within one month of enrollment
Measurement of serum specific IgE to betalactoglobulin.
Time Frame: Within one month of enrollment
Measurement of serum specific IgE to betalactoglobulin.
Within one month of enrollment
Measurement of serum specific IgE to ovomucoid.
Time Frame: Within one month of enrollment
Measurement of serum specific IgE to ovomucoid.
Within one month of enrollment
Measurement of serum specific IgE to ovalbumin.
Time Frame: Within one month of enrollment
Measurement of serum specific IgE to ovalbumin.
Within one month of enrollment
Laboratory measurement of vitamin D concentration.
Time Frame: Within one month of enrollment
Laboratory measurement of vitamin D concentration.
Within one month of enrollment
Laboratory measurement of serum calcium concentration.
Time Frame: Within one month of enrollment
Laboratory measurement of serum calcium concentration.
Within one month of enrollment
Laboratory measurement of serum phosphorus concentration.
Time Frame: Within one month of enrollment
Laboratory measurement of serum phosphorus concentration.
Within one month of enrollment
Laboratory measurement of serum iron concentration.
Time Frame: Within one month of enrollment
Laboratory measurement of serum iron concentration.
Within one month of enrollment
Laboratory measurement of serum magnesium concentration.
Time Frame: Within one month of enrollment
Laboratory measurement of serum magnesium concentration.
Within one month of enrollment
Laboratory measurement of serum interleukin 25.
Time Frame: Within one month of enrollment
Laboratory measurement of serum interleukin 25.
Within one month of enrollment
Laboratory measurement of serum interleukin 33.
Time Frame: Within one month of enrollment
Laboratory measurement of serum interleukin 33.
Within one month of enrollment
Laboratory measurement of serum interleukin 17.
Time Frame: Within one month of enrollment
Laboratory measurement of serum interleukin 17.
Within one month of enrollment
Laboratory measurement of serum interleukin 13.
Time Frame: Within one month of enrollment
Laboratory measurement of serum interleukin 13.
Within one month of enrollment
Laboratory measurement of serum interleukin 10.
Time Frame: Within one month of enrollment
Laboratory measurement of serum interleukin 10.
Within one month of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vilnius University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ieva Adomaite, MD, Vilnius University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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