NCT05943704

Brief Summary

This study aims to determine the frequency of allergy to beef meat in children with allergy to cow's milk by serum measurement. Also, the study aims to assess the sensitivity and specificity of beef IgE in relation to gold standardized of elimination challenge test and to assess effect of eating of cooked meat on symptoms of allergy in those proven to have either CMA alone +/- beef allergy (by serology).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2024

Completed
Last Updated

May 7, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

July 6, 2023

Last Update Submit

May 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Children with Positive IgE for beef.

    6 months

Study Arms (1)

Children with cow milk allergy.

EXPERIMENTAL

Beef introduction for children proven to have cow milk protein allergy

Dietary Supplement: beef broth

Interventions

beef brothDIETARY_SUPPLEMENT

It indicates if the child has allergy of Beef or not.

Children with cow milk allergy.

Eligibility Criteria

Age7 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children from seven months to three years old newly diagnosed with cow milk allergy at Gastroenterology Unit and Allergy, Rheumatology and Immunology Unit.

You may not qualify if:

  • Critically ill children.
  • Patients diagnosed as immune deficiency.
  • Patients receiving long term steroid therapy or anti-histaminic.
  • Patients who had anaphylaxis or severe reactions from milk
  • Patients with skin diseases which can mask skin reactions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, 11566, Egypt

Location

Related Publications (10)

  • Fiocchi A, Restani P, Riva E, Mirri GP, Santini I, Bernardo L, Galli CL. Heat treatment modifies the allergenicity of beef and bovine serum albumin. Allergy. 1998 Aug;53(8):798-802. doi: 10.1111/j.1398-9995.1998.tb03977.x.

    PMID: 9722230BACKGROUND
  • Gonzales-Gonzalez VA, Diaz AM, Fernandez K, Rivera MF. Prevalence of food allergens sensitization and food allergies in a group of allergic Honduran children. Allergy Asthma Clin Immunol. 2018 Jun 18;14:23. doi: 10.1186/s13223-018-0245-x. eCollection 2018.

    PMID: 29946340BACKGROUND
  • Espin Jaime B, Diaz Martin JJ, Blesa Baviera LC, Claver Monzon A, Hernandez Hernandez A, Garcia Burriel JI, Merida MJG, Pinto Fernandez C, Coronel Rodriguez C, Roman Riechmann E, Ribes Koninckx C. [Non-IgE-mediated cow's milk allergy: Consensus document of the Spanish Society of Paediatric Gastroenterology, Hepatology, and Nutrition (SEGHNP), the Spanish Association of Paediatric Primary Care (AEPAP), the Spanish Society of Extra-hospital Paediatrics and Primary Health Care (SEPEAP), and the Spanish Society of Paediatric ClinicaL Immunology, Allergy, and Asthma (SEICAP)]. An Pediatr (Engl Ed). 2019 Mar;90(3):193.e1-193.e11. doi: 10.1016/j.anpedi.2018.11.007. Epub 2019 Jan 19. Spanish.

    PMID: 30665859BACKGROUND
  • Martelli A, De Chiara A, Corvo M, Restani P, Fiocchi A. Beef allergy in children with cow's milk allergy; cow's milk allergy in children with beef allergy. Ann Allergy Asthma Immunol. 2002 Dec;89(6 Suppl 1):38-43. doi: 10.1016/s1081-1206(10)62121-7.

    PMID: 12487203BACKGROUND
  • Martorell A, Plaza AM, Bone J, Nevot S, Garcia Ara MC, Echeverria L, Alonso E, Garde J, Vila B, Alvaro M, Tauler E, Hernando V, Fernandez M. Cow's milk protein allergy. A multi-centre study: clinical and epidemiological aspects. Allergol Immunopathol (Madr). 2006 Mar-Apr;34(2):46-53. doi: 10.1157/13086746.

    PMID: 16606545BACKGROUND
  • Paschke A, Besler M. Stability of bovine allergens during food processing. Ann Allergy Asthma Immunol. 2002 Dec;89(6 Suppl 1):16-20. doi: 10.1016/s1081-1206(10)62117-5.

    PMID: 12487199BACKGROUND
  • Skypala IJ, Venter C, Meyer R, deJong NW, Fox AT, Groetch M, Oude Elberink JN, Sprikkelman A, Diamandi L, Vlieg-Boerstra BJ; Allergy-focussed Diet History Task Force of the European Academy of Allergy and Clinical Immunology. The development of a standardised diet history tool to support the diagnosis of food allergy. Clin Transl Allergy. 2015 Feb 19;5:7. doi: 10.1186/s13601-015-0050-2. eCollection 2015.

    PMID: 25741437BACKGROUND
  • Soares-Weiser K, Takwoingi Y, Panesar SS, Muraro A, Werfel T, Hoffmann-Sommergruber K, Roberts G, Halken S, Poulsen L, van Ree R, Vlieg-Boerstra BJ, Sheikh A; EAACI Food Allergy and Anaphylaxis Guidelines Group. The diagnosis of food allergy: a systematic review and meta-analysis. Allergy. 2014 Jan;69(1):76-86. doi: 10.1111/all.12333. Epub 2013 Dec 14.

    PMID: 24329961BACKGROUND
  • Venter C, Brown T, Shah N, Walsh J, Fox AT. Diagnosis and management of non-IgE-mediated cow's milk allergy in infancy - a UK primary care practical guide. Clin Transl Allergy. 2013 Jul 8;3(1):23. doi: 10.1186/2045-7022-3-23.

    PMID: 23835522BACKGROUND
  • Werfel SJ, Cooke SK, Sampson HA. Clinical reactivity to beef in children allergic to cow's milk. J Allergy Clin Immunol. 1997 Mar;99(3):293-300. doi: 10.1016/s0091-6749(97)70045-9.

    PMID: 9058683BACKGROUND

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 13, 2023

Study Start

September 15, 2023

Primary Completion

May 30, 2024

Study Completion

August 28, 2024

Last Updated

May 7, 2025

Record last verified: 2025-04

Locations