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Completed

NCT Number: NCT04330092

Diagnosis of Cow's Milk Protein Allergy

The study will assess the diagnosis of cow's milk protein allergy (CMPA) among infant and children in assiut university children hospital using skin prick test and specific serum IgE as well as their management.

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Key information

Conditions

Cow's Milk Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

1 day–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assuit University

Asyut, Egypt

About this study

Food allergy is a reproducible specific immune response to exposure to a given food. Cow's milk protein allergy (CMPA) is clinically abnormal reaction to cow's milk protein (CMP) via immune mechanisms triggered by milk protein (Boyce etal.,2010).

According to European academy for allergy and clinical immunology (EAACI) and the world allergy organization (wao) , a hypersensitivity reaction to cow's milk involving the immune system can be called as CMPA. There is difference between CMPA and non-allergic cow's milk intolerance (e.g lactose intolerance) which occurs as a result of lactase deficiency without involvement of the immune system (Venter etal.,2013).

CMPA is categorized into immunoglobulin IgE mediated , non -IgE mediated ,or mixed CMPA (Sicherer etal.,2001).

1.9% to 4.9% prevalence of CMPA among children with a peak in prevalence (2-3%) in the first year of life and prevalence of <1% in children aged >=6 years (koletzko etal.,2012).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • - Exclusively breast feeding ,breast-fed infants with supplementary foods and non-breast fed infants with supplementary foods who complain from either frequent regurgitation, vomiting,diarrhea,constipation (with/without perianal rash) ,blood in stool or pallor.

Exclusion criteria

  • : Infant and child with gastrointestinal symptoms due to specific etiology.

Treatment and study plan

Primary outcomes

  1. diagnosis of cow's protein allergy among infants and children from 1st day of life-2 years

    Time frame: baseline

    compare between diagnosis by skin prick test and specific serum IgE

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Diagnosis of Cow's Milk Protein Allergy Among Infants and Children in Assiut University Children Hospital

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2020
Registry last updated
Sep 16, 2021

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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