Cow Milk AllergyNCT05943704
The Frequency of Beef Allergy in Children With Cow Milk Allergy
A study testing beef broth in people with Cow Milk Allergy, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 months to 3 years
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- beef broth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2023to 28 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from seven months to three years old newly diagnosed with cow milk allergy at Gastroenterology Unit and Allergy, Rheumatology and Immunology Unit.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Full medical history taking:
Personal history: Name, age, sex, order of birth, residence, and consanguinity. Complaint.
Present history:
- Gastrointestinal symptoms
- Vomiting (yes/no): If yes: onset, course, duration, frequency, force, color, relation to meal, relation to posture and need for IV fluid.
- Hematemesis (yes/no): If yes: onset, course, duration, frequency, color, need for resuscitation and associated melena.
- Diarrhea (yes/no): If yes: onset, course, duration, frequency, consistency, blood in stool and straining.
- Constipation: (yes/no): If yes: onset, course, duration, frequency, consistency, blood in stool and straining.
- Other symptoms: colics, nausea, distension, dysphagia, and failure to gain weight.
- Associated systemic manifestations (Allergic manifestations) including:
- Skin allergy (eczema, urticaria, napkin dermatitis).
- Chest allergy (wheezing, croup).
- ENT manifestations (allergic rhinitis).
- Anaphylactic shock.
- Dietary and nutritional history:
- Breast Feeding: (yes/no) If Yes exclusive for how long?
- Artificial feeding: Age of start, type of formula and indication
- 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.
- Conditions
- Cow Milk Allergy
- Being tested
- beef broth
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beef brothDietary supplement
It indicates if the child has allergy of Beef or not.
| Study group | Role | What they receive |
|---|---|---|
| Children with cow milk allergy. | Experimental | Beef introduction for children proven to have cow milk protein allergy Receives: Dietary Supplement: beef broth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children with Positive IgE for beef.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start15 Sep 2023
- Primary completion30 May 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cow Milk AllergyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943704
- Sponsor's protocol ID
- FMASU MS322/2022
- Status last verified
- Apr 2025
- First submitted
- 6 Jul 2023
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 9722230Gonzales-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 29946340Espin 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 30665859Martelli 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 12487203Martorell 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 16606545Paschke 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 12487199Skypala 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 25741437Soares-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 24329961Venter 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 23835522Werfel 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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency of Beef Allergy in Children With Cow Milk Allergy
- ClinicalTrials.gov ID
- NCT05943704
- Acronym / sponsor ID
- FMASU MS322/2022
- Conditions
- Cow Milk Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Full medical history taking:
Personal history: Name, age, sex, order of birth, residence, and consanguinity. Complaint.
Present history:
- Gastrointestinal symptoms
- Vomiting (yes/no): If yes: onset, course, duration, frequency, force, color, relation to meal, relation to posture and need for IV fluid.
- Hematemesis (yes/no): If yes: onset, course, duration, frequency, color, need for resuscitation and associated melena.
- Diarrhea (yes/no): If yes: onset, course, duration, frequency, consistency, blood in stool and straining.
- Constipation: (yes/no): If yes: onset, course, duration, frequency, consistency, blood in stool and straining.
- Other symptoms: colics, nausea, distension, dysphagia, and failure to gain weight.
- Associated systemic manifestations (Allergic manifestations) including:
- Skin allergy (eczema, urticaria, napkin dermatitis).
- Chest allergy (wheezing, croup).
- ENT manifestations (allergic rhinitis).
- Anaphylactic shock.
- Dietary and nutritional history:
- Breast Feeding: (yes/no) If Yes exclusive for how long?
- Artificial feeding: Age of start, type of formula and indication
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cow milk allergy. | Experimental | Dietary Supplement: beef brothBeef introduction for children proven to have cow milk protein allergy |
Who may qualify
- Ages
- 7 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children from seven months to three years old newly diagnosed with cow milk allergy at Gastroenterology Unit and Allergy, Rheumatology and Immunology Unit.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beef brothIt indicates if the child has allergy of Beef or not. | Dietary supplement | Children with cow milk allergy. |
Primary outcome
Children with Positive IgE for beef.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Background: PubMed 9722230Fiocchi 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.
- Background: PubMed 29946340Gonzales-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.
- Background: PubMed 30665859Espin 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.
- Background: PubMed 12487203Martelli 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.
- Background: PubMed 16606545Martorell 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.
- Background: PubMed 12487199Paschke 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.
- Background: PubMed 25741437Skypala 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.
- Background: PubMed 24329961Soares-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.
- Background: PubMed 23835522Venter 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.
- Background: PubMed 9058683Werfel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beef broth in people with Cow Milk Allergy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children with Positive IgE for beef. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05943704, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.