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

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.

Study Overview

• Status: Unknown
• Conditions: Food Allergy
• Intervention / Treatment: Diagnostic test: oral food challenge with cow's milk proteins

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tatiana Jamer, PhD; Phone Number: +48 508 124 186; Email: tatiana.jamer@umed.wroc.pl
• Study Contact Backup: Name: Agnieszka Borys-Iwanicka, PhD; Phone Number: +48 692 082 313; Email: agnieszka.borys-iwanicka@umed.wroc.pl

Study Locations

• Poland
  • Wrocław, Poland, 50-367
    • Recruiting
    • Wroclaw Medical University
    • Contact: Tatiana Jamer, PhD; Phone Number: +48 508 124 186; Email: tatiana.jamer@umed.wroc.pl
    • Contact: Agnieszka Borys-Iwanicka, PhD; Phone Number: +48 692 082 313; Email: agnieszka.borys-iwanicka@umed.wroc.pl
    • Principal Investigator: Tatiana Jamer, PhD
    • Sub-Investigator: Agnieszka Borys-Iwanicka, PhD
    • Sub-Investigator: Anna Dancewicz, MD
    • Sub-Investigator: Paulina Kuchalska, MD
    • Sub-Investigator: Andrzej Stawarski, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 13 mo to 15 yo children diagnosed with Cow's Milk Allergy; oral food challenge with cow's milk proteins	Diagnostic test: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wroclaw Medical University
• Investigators: Principal Investigator: Tatiana Jamer, PhD, Wroclaw Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 14, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: children; food allergy; oral food challenge
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: OFC2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No