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

NCT04312438 | Unknown

• 1 other identifier: OFC2020
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy

Keywords

oral food challenge; food allergy; children

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• 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

  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

  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

  before and 12 weeks after oral food challenge

Study Arms (1)

13 mo to 15 yo children diagnosed with Cow's Milk Allergy

EXPERIMENTAL

oral food challenge with cow's milk proteins

Diagnostic Test: oral food challenge with cow's milk proteins

Interventions

oral food challenge with cow's milk proteins DIAGNOSTIC_TEST

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

13 mo to 15 yo children diagnosed with Cow's Milk Allergy

Eligibility Criteria

• Age: 13 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw Medical University: lead

Study Sites (1)

Wroclaw Medical University

Wroclaw, 50-367, Poland

RECRUITING

Related Publications (6)

• 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.

  PMID: 24909706 BACKGROUND

• 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.

  PMID: 28856837 BACKGROUND

• 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.

  PMID: 28283161 BACKGROUND

• 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.

  PMID: 19500710 BACKGROUND

• 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.

  PMID: 30377836 BACKGROUND

• 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.

  PMID: 29132673 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Tatiana Jamer, PhD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana Jamer, PhD

CONTACT

+48 508 124 186; tatiana.jamer@umed.wroc.pl

Agnieszka Borys-Iwanicka, PhD

CONTACT

+48 692 082 313; agnieszka.borys-iwanicka@umed.wroc.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Inverstigator

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 18, 2020
• Study Start: June 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

PL (1)