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
About this trial
This is an interventional diagnostic trial for Cow Milk Allergy
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 .
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
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
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Diagnosis of Cow's Milk Protein Allergy Among Infants and Children in Assuit University Children Hospital
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