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
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).
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:
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.
Associated systemic manifestations (Allergic manifestations) including:
Dietary and nutritional history:
Artificial feeding:
Age of start, type of formula and indication
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.
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 →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.
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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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Beef introduction for children proven to have cow milk protein allergy
Dietary Supplement: beef broth
It indicates if the child has allergy of Beef or not.
Children with Positive IgE for beef.
Time frame: 6 months
Plan to share: Undecided
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.
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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