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NCT04330092 Clinical Trial

Diagnosis of Cow's Milk Protein Allergy

Cow's Milk Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04330092
Other study ID # cow's milk allergy
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2020
Est. completion date September 1, 2021

Study information
Verified date September 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date September 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Egypt Assuit University Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary diagnosis of cow's protein allergy among infants and children from 1st day of life-2 years compare between diagnosis by skin prick test and specific serum IgE baseline
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