ClinicalTrials.gg
CompletedNCT05943704Updated May 7, 2025

The Frequency of Beef Allergy in Children With Cow Milk Allergy

An interventional study of beef broth in Cow Milk Allergy, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 7 Months to 3 Years. Per ClinicalTrials.gov, last updated 2025-05-07.

Sponsored by Ain Shams University · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Not applicable
Ages
7 Months to 3 Years
Sex
All
01

Study 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).

Read the detailed description

Milk has been recognized as a leading cause for food allergy in children. It is recognized that there is cross-reactivity of bovine serum albumin and bovine γ-globulin which are present in both milk and beef. Thus, children with cow's milk allergy may be instructed to avoid beef.

The true prevalence of beef allergy has been studied only in few research. This current study will add a tertiary center experience in relation of beef allergy to cow's milk protein allergy to fill the gap of knowledge regarding this subject especially in Egypt.

Study Procedures:

Cases will be managed according to the protocol of gastroenterology unit and Allergy, Rheumatology and Immunology Unit, and will be subjected to:

Informed consent: will be obtained from all patient's parents or legal guardians.

All included cases will be subjected to the following phases of the study:

Phase Ⅰ: Recruitment

I. Full medical history taking:

Personal history: Name, age, sex, order of birth, residence, and consanguinity. Complaint.

Present history:

  1. Gastrointestinal symptoms

    1. Vomiting (yes/no):

      If yes: onset, course, duration, frequency, force, color, relation to meal, relation to posture and need for IV fluid.

    2. Hematemesis (yes/no):

      If yes: onset, course, duration, frequency, color, need for resuscitation and associated melena.

    3. Diarrhea (yes/no):

      If yes: onset, course, duration, frequency, consistency, blood in stool and straining.

    4. Constipation: (yes/no):

      If yes: onset, course, duration, frequency, consistency, blood in stool and straining.

    5. Other symptoms: colics, nausea, distension, dysphagia, and failure to gain weight.
  2. Associated systemic manifestations (Allergic manifestations) including:

    1. Skin allergy (eczema, urticaria, napkin dermatitis).
    2. Chest allergy (wheezing, croup).
    3. ENT manifestations (allergic rhinitis).
    4. Anaphylactic shock.
  3. Dietary and nutritional history:

    1. Breast Feeding: (yes/no) If Yes exclusive for how long?
    2. Artificial feeding:

      Age of start, type of formula and indication

    3. Weaning:

Time of start, type of food given (each food and time of introduction especially cow's milk and CMPs) and any problems during weaning (gastrointestinal, respiratory, or skin allergies).

Past history: mode of delivery, NICU admission. Medication history: Type of medications, antireflux medications, laxatives, probiotic.

Family history: atopy, other siblings with CMPA.

II. Careful Clinical examination:

Anthropometric measurements: (weight, height, Wt/Ht ratio and occipto-frontal circumference) Signs of allergy: (atopic dermatitis- allergic rhinitis). Abdominal examination: (Distension-tenderness-organomegaly) Perianal inflammation, napkin rash. All patients suspected of having cow milk allergy will be subjected to elimination re-challenge test (Dupont, 2014).

All patients included in the study were instructed initially to avoid meat products as per protocol of Ain Shams University for 4 weeks.

Blood samples for IgE for beef will be withdrawn at time of enrollment.

Phase Ⅱ:

Patients with history of anaphylaxis will be excluded from this phase. During the oral food challenge (OFC) procedure, patients will be monitored and regularly re-examined prior to each dose and at first signs of reaction. Total dose will be divided into six incremental portions, where every next dose will be double of the previous dose as follows: 1, 2, 4, 8 and 16 g. In case of suspected severe reaction, a much smaller dose was decided (Gonzales González et al. 2018). In cases of anaphylaxis, patients will be given intramuscular epinephrine in the lateral aspect of the thigh and the dose will be calculated based on patient's weight. Dose will be prepared prior to the procedure to avoid any delay.

In case of milder skin reaction or any type of reaction as bronchospasm it will be managed by oral steroids, antihistaminic + any symptom treatment based on what the patient develops. Smaller doses will be given to those who have mild or moderate reaction and those who develop will not continue the OFS.

02

Conditions studied

  • Cow Milk Allergy

Browse trials for

03

In context

Milk Hypersensitivity

147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.

This study's enrollment of 96 is above the median of 68 across 95 interventional studies indexed under Milk Hypersensitivity.

Browse Milk Hypersensitivity studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Months to 3 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Critically ill children.
  • Patients diagnosed as immune deficiency.
  • Patients receiving long term therapy or anti-histaminic.
  • Patients who had anaphylaxis or severe reactions from milk
  • Patients with skin diseases which can mask skin reactions
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Children with cow milk allergy.

    Beef introduction for children proven to have cow milk protein allergy

    Dietary Supplement: beef broth

Interventions

  • Dietary supplementbeef broth

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

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What researchers measure

Primary outcomes

  1. Children with Positive IgE for beef.

    Time frame: 6 months

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Study locations

1 site
  • Faculty of Medicine, Ain Shams University
    Cairo, 11566, Egypt
08

References and documents

Publications

  • 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. PubMed 9722230 ↗
  • 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. PubMed 29946340 ↗
  • 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. PubMed 30665859 ↗
  • 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. PubMed 12487203 ↗
  • 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. PubMed 16606545 ↗
  • 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. PubMed 12487199 ↗
  • 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. PubMed 25741437 ↗
  • 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. PubMed 24329961 ↗
  • 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. PubMed 23835522 ↗
  • 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. PubMed 9058683 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2023 to primary completion in May 2024, 8 months.

Of 34 interventional studies with no phase under Milk Hypersensitivity, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 48. This study's 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2023
First posted
Jul 13, 2023
StartActual
Sep 15, 2023
Primary completionActual
May 30, 2024
CompletionActual
Aug 28, 2024
Last update
May 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05943704
Responsible party
Sponsor
First posted
Jul 13, 2023
Start date
Sep 15, 2023
Primary completion
May 30, 2024
Completion
Aug 28, 2024
Last update
May 7, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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