search
Back to results

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

Primary Purpose

Cow Milk Allergy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
skin prick test - specific serum IgE
Sponsored by
Assiut University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cow Milk Allergy

Eligibility Criteria

1 Day - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age : from first day of life - 2 years
  2. exclusively breast feeding,breast-fed infants with supplementary foods and non-breast-fed infants with supplementary foods who complain from either frequentregurgitation,vomiting,diarrhea,constipation)with/without perianal rash),bloodin stool or pallor.

Exclusion Criteria:

  • Infant and child with gastrointestinal symptoms due to specific aetiology .

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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 specificserumIgE

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2018
    Last Updated
    March 3, 2018
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03456479
    Brief Title
    Diagnosis of Cow's Milk Protein Allergy Among Infants and Children in Assuit University Children Hospital
    Official Title
    Diagnosis of Cow's Milk Protein Allergy Among Infants and Children in Assuit University
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2019 (Anticipated)
    Primary Completion Date
    March 1, 2020 (Anticipated)
    Study Completion Date
    September 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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
    Detailed Description
    Food allergy is a reproducible specific immune response to the exposure to a given food. Cow's milk protein allergy (CMPA) is a clinically abnormal reaction to cow's milk protein (CMP) via immune mechanisms triggered by milk protein (Boyce etal., 2010) . According to the 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.glactose 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(Sichereretal ., 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(Koletzkoetal ., 2012) .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cow Milk Allergy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    skin prick test - specific serum IgE
    Intervention Description
    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 specificserumIgE
    Primary Outcome Measure Information:
    Title
    Diagnosis of cow's milk protein allergy
    Description
    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 specificserumIgE
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age : from first day of life - 2 years exclusively breast feeding,breast-fed infants with supplementary foods and non-breast-fed infants with supplementary foods who complain from either frequentregurgitation,vomiting,diarrhea,constipation)with/without perianal rash),bloodin stool or pallor. Exclusion Criteria: Infant and child with gastrointestinal symptoms due to specific aetiology .
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gamal N Rady, Bachelor
    Phone
    01220108053
    Email
    gamal.nady@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shereen M Galal, Doctorate
    Phone
    01003162310

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15784102
    Citation
    Celik-Bilgili S, Mehl A, Verstege A, Staden U, Nocon M, Beyer K, Niggemann B. The predictive value of specific immunoglobulin E levels in serum for the outcome of oral food challenges. Clin Exp Allergy. 2005 Mar;35(3):268-73. doi: 10.1111/j.1365-2222.2005.02150.x.
    Results Reference
    background
    PubMed Identifier
    18791102
    Citation
    Brill H. Approach to milk protein allergy in infants. Can Fam Physician. 2008 Sep;54(9):1258-64.
    Results Reference
    background
    PubMed Identifier
    24749081
    Citation
    Vandenplas Y, De Greef E, Devreker T. Treatment of Cow's Milk Protein Allergy. Pediatr Gastroenterol Hepatol Nutr. 2014 Mar;17(1):1-5. doi: 10.5223/pghn.2014.17.1.1. Epub 2014 Mar 31.
    Results Reference
    background
    PubMed Identifier
    11343044
    Citation
    Sicherer SH, Noone SA, Koerner CB, Christie L, Burks AW, Sampson HA. Hypoallergenicity and efficacy of an amino acid-based formula in children with cow's milk and multiple food hypersensitivities. J Pediatr. 2001 May;138(5):688-93. doi: 10.1067/mpd.2001.113007.
    Results Reference
    background
    PubMed Identifier
    22569527
    Citation
    Koletzko S, Niggemann B, Arato A, Dias JA, Heuschkel R, Husby S, Mearin ML, Papadopoulou A, Ruemmele FM, Staiano A, Schappi MG, Vandenplas Y; European Society of Pediatric Gastroenterology, Hepatology, and Nutrition. Diagnostic approach and management of cow's-milk protein allergy in infants and children: ESPGHAN GI Committee practical guidelines. J Pediatr Gastroenterol Nutr. 2012 Aug;55(2):221-9. doi: 10.1097/MPG.0b013e31825c9482.
    Results Reference
    background
    PubMed Identifier
    23835522
    Citation
    Venter C, Brown T, Shah N, Walsh J, Fox AT. Diagnosis and management of non-IgE-mediated cow's milk allergy in infancy - a UK primary care practical guide. Clin Transl Allergy. 2013 Jul 8;3(1):23. doi: 10.1186/2045-7022-3-23.
    Results Reference
    background
    PubMed Identifier
    21134576
    Citation
    NIAID-Sponsored Expert Panel; Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, Fenton MJ, Arshad SH, Bahna SL, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, Eichenfield L, Furuta GT, Hanifin JM, Jones C, Kraft M, Levy BD, Lieberman P, Luccioli S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger JM. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010 Dec;126(6 Suppl):S1-58. doi: 10.1016/j.jaci.2010.10.007.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs