Safety of Oral Food Challenge With Cow's Milk Proteins in Children With Food Allergy
NCT ID: NCT04312438
Last Updated: 2020-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1 participants
INTERVENTIONAL
2020-06-30
2022-03-31
Brief Summary
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Detailed Description
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The study covers children over 12 months of age diagnosed with cow's milk allergy, treated with a non-dairy elimination diet based on extensively-hydrolyzed formulas or amino acid formulas, admitted to the Department of Pediatrics, Gastroenterology and Nutrition to conduct an open oral food challenge. In all children, after appropriate assessment and qualification (interview, physical examination, skin prick tests, results of allergen - specific immunoglobulin E (IgE), total blood count, fecal calprotectin and lactoferrin), an oral food challenge test with cow's milk will be performed. The oral food challenge test will be carried out in accordance with current standards and with child protection in the event of an adverse reactions. During the food challenge test (first 24 hours), after 2 weeks (phone survey) and 3 months after the test (visit to the Department) the frequency, severity and type of allergic reactions and cow's milk protein tolerance will be assessed. The safety of oral food challenge with cow's milk protein in children previously fed with extensively - hydrolyzed formulas or amino acid formulas will be compared. The results of allergy tests, total blood count and intestinal inflammatory markers (fecal calprotectin and fecal lactoferrin) will also be assessed before and 12 weeks after oral food challenge. The assessment of the incidence and severity of allergic reactions and tolerance of cow's milk proteins after introduction into the diet in children challenged with cow's milk proteins may help to establish guidelines on the qualifications and how to conduct an oral challenge test.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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13 mo to 15 yo children diagnosed with Cow's Milk Allergy
oral food challenge with cow's milk proteins
oral food challenge with cow's milk proteins
in children with diagnosed Cow's Milk Allergy open oral food challenge test with cow's milk protein (milk formula in children up to 3 yo, cow,s milk after 3 yo) will be carried out
Interventions
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oral food challenge with cow's milk proteins
in children with diagnosed Cow's Milk Allergy open oral food challenge test with cow's milk protein (milk formula in children up to 3 yo, cow,s milk after 3 yo) will be carried out
Eligibility Criteria
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Inclusion Criteria
* children diagnosed with cow's milk allergy treated with a dairy-free diet
* informed consent of the child's parents/legal guardians to participate in the study
Exclusion Criteria
* positive skin prick test with cow's milk proteins
* milk specific serum IgE values \> 17,5 kU/L
* age below 13 moths
* no consent of the child's parents/legal guardians to participate in the study
13 Months
15 Years
ALL
No
Sponsors
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Wroclaw Medical University
OTHER
Responsible Party
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Tatiana Jamer
Principal Inverstigator
Principal Investigators
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Tatiana Jamer, PhD
Role: PRINCIPAL_INVESTIGATOR
Wroclaw Medical University
Locations
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Wroclaw Medical University
Wroclaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Muraro A, Werfel T, Hoffmann-Sommergruber K, Roberts G, Beyer K, Bindslev-Jensen C, Cardona V, Dubois A, duToit G, Eigenmann P, Fernandez Rivas M, Halken S, Hickstein L, Host A, Knol E, Lack G, Marchisotto MJ, Niggemann B, Nwaru BI, Papadopoulos NG, Poulsen LK, Santos AF, Skypala I, Schoepfer A, Van Ree R, Venter C, Worm M, Vlieg-Boerstra B, Panesar S, de Silva D, Soares-Weiser K, Sheikh A, Ballmer-Weber BK, Nilsson C, de Jong NW, Akdis CA; EAACI Food Allergy and Anaphylaxis Guidelines Group. EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy. Allergy. 2014 Aug;69(8):1008-25. doi: 10.1111/all.12429. Epub 2014 Jun 9.
Roberts G. Food challenges, the risks and benefits. Clin Exp Allergy. 2017 Sep;47(9):1106-1107. doi: 10.1111/cea.12999. No abstract available.
Beigelman A. To Eat or Not to Eat? Introduction of Food After Negative Oral Food Challenge. J Allergy Clin Immunol Pract. 2017 Mar-Apr;5(2):477-478. doi: 10.1016/j.jaip.2016.09.005. No abstract available.
Nowak-Wegrzyn A, Assa'ad AH, Bahna SL, Bock SA, Sicherer SH, Teuber SS; Adverse Reactions to Food Committee of American Academy of Allergy, Asthma & Immunology. Work Group report: oral food challenge testing. J Allergy Clin Immunol. 2009 Jun;123(6 Suppl):S365-83. doi: 10.1016/j.jaci.2009.03.042.
Cox AL, Nowak-Wegrzyn A. Innovation in Food Challenge Tests for Food Allergy. Curr Allergy Asthma Rep. 2018 Oct 30;18(12):74. doi: 10.1007/s11882-018-0825-3.
Gupta M, Cox A, Nowak-Wegrzyn A, Wang J. Diagnosis of Food Allergy. Immunol Allergy Clin North Am. 2018 Feb;38(1):39-52. doi: 10.1016/j.iac.2017.09.004. Epub 2017 Oct 23.
Other Identifiers
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OFC2020
Identifier Type: -
Identifier Source: org_study_id
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