Safety of Oral Food Challenge With Cow's Milk Proteins in Children With Food Allergy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety of Oral Food Challenge With Cow's Milk Proteins in Children With Food Allergy

Conditions
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Food Allergy

Intervention / Treatment
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* Diagnostic Test: oral food challenge with cow's milk proteins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 13 mo to 15 yo children diagnosed with Cow's Milk Allergy<br>oral food challenge with cow's milk proteins | Diagnostic Test: oral food challenge with cow's milk proteins<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of allergic reaction during and after oral food challenge assessed by the occurrence of allergic symptoms in children | assessment of type, severity and frequency of food allergy symptoms (allergic skin changes, gastrointestinal and respiratory tract symptoms) that occurred during and after oral food challenge, based on medical history data and physical examination collected by a doctor | up to 12 weeks after oral food challenge | 
| Change of hemoglobin level after 12 weeks after oral food challenge | hemoglobin concentration in venous blood measured in g/dl | before and 12 weeks after oral food challenge | 
| Changes in skin prick test results 12 weeks after oral food challenge | skin prick test with milk, egg yolk, egg white, chicken, wheat, fish before and 12 weeks after oral food challenge | before and 12 weeks after oral food challenge | 
| Changes in allergen - specific IgE pediatric panel results 12 weeks after oral food challenge | allergen - specific IgE pediatric panel results (allergen - specific IgE concentration measured in kU/l, classified in grades 0-6) before and 12 weeks after oral food challenge | before and 12 weeks after oral food challenge | 
| Change of fecal calprotectin concentrations (intestinal inflammatory marker) after 12 weeks after oral food challenge | concentration of fecal calprotectin in the feces measured in ug/g before and 12 weeks afte oral food challenge | before and 12 weeks after oral food challenge | 
| Change of fecal lactoferrin concentrations (intestinal inflammatory marker) after 12 weeks after oral food challenge | concentration of fecal lactoferrin in the feces measured in μg/g before and 12 weeks afte oral food challenge | before and 12 weeks after oral food challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | assessment of type, severity and frequency of food allergy symptoms (allergic skin changes, gastrointestinal and respiratory tract symptoms) that occurred during and after oral food challenge, based on medical history data and physical examination collected by a doctor | up to 12 weeks after oral food challenge | 
| Comparison of changes in skin prick test results between children previously fed with extensively - hydrolyzed formulas and amino acid formulas | skin prick test with milk, egg yolk, egg white, chicken, wheat, fish before and 12 weeks after oral food challenge | before and 12 weeks after oral food challenge | 
| comparison of changes in allergen - specific IgE pediatric panel results between children previously fed with extensively - hydrolyzed formulas and amino acid formulas | allergen - specific IgE pediatric panel results (allergen - specific IgE concentration measured in kU/l, classified in grades 0-6) before and 12 weeks after oral food | before and 12 weeks after oral food challenge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral food challenge, food allergy, children