Clinical trial NCT04312438: Safety of Oral Food Challenge With Cow's Milk Proteins in Children With Food Allergy
Official title: Safety of Oral Food Challenge With Cow's Milk Proteins in Children With Food Allergy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Allergy
Keywords: oral food challenge
food allergy
children
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 1
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to assess the safety of an oral food challenge (OFC) with cow's milk proteins and to assess the tolerance of cow's milk proteins in children with a food allergy after introducing cow's milk into the diet.

Detailed description: The aim of the study is to assess the safety of an oral food challenge test with cow's milk proteins and to assess the tolerance of cow's milk proteins in children with food allergies after introducing cow's milk into the diet.

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.

Eligibility criteria: Inclusion Criteria:

* children aged from 13 months to 15 years
* 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:

* occurrence of anaphylactic reaction after ingestion cow's milk proteins less than 12 months
* 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

Primary outcomes:
measure: Incidence of allergic reaction during and after oral food challenge assessed by the occurrence of allergic symptoms in children
timeFrame: up to 12 weeks after oral food challenge
measure: Change of hemoglobin level after 12 weeks after oral food challenge
timeFrame: before and 12 weeks after oral food challenge
measure: Changes in skin prick test results 12 weeks after oral food challenge
timeFrame: before and 12 weeks after oral food challenge
measure: Changes in allergen - specific IgE pediatric panel results 12 weeks after oral food challenge
timeFrame: before and 12 weeks after oral food challenge
measure: Change of fecal calprotectin concentrations (intestinal inflammatory marker) after 12 weeks after oral food challenge
timeFrame: before and 12 weeks after oral food challenge
measure: Change of fecal lactoferrin concentrations (intestinal inflammatory marker) after 12 weeks after oral food challenge
timeFrame: before and 12 weeks after oral food challenge
Secondary outcomes:
measure: Comparison of the incidence of allergic reaction during and after oral food challenge with cow's milk protein between children previously fed with extensively - hydrolyzed formulas and amino acid formulas
timeFrame: up to 12 weeks after oral food challenge
measure: Comparison of changes in skin prick test results between children previously fed with extensively - hydrolyzed formulas and amino acid formulas
timeFrame: before and 12 weeks after oral food challenge
measure: comparison of changes in allergen - specific IgE pediatric panel results between children previously fed with extensively - hydrolyzed formulas and amino acid formulas
timeFrame: before and 12 weeks after oral food challenge
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw Medical University
Study officials:
affiliation: Wroclaw Medical University
name: Tatiana Jamer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.