An interventional study of Direct Milk antigen reintroduction and Milk ladder in Cow Milk Allergy and Tolerance, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 9 Months to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Ain Shams University · Not applicable, Interventional, and Other
Majority of children outgrow their allergies, however there are two different methods to re-introduce milk products in the infant diet either direct milk intake in escalating doses or milk ladder, starting with baked milk products instead of pure milk.
This study aims to compare rate of tolerance after milk reintroduction among patient with cow milk protein allergy (CMPA) diagnosed by elimination re-challenge test after six months of elimination diet by milk ladder versus direct milk intake.
CMPA is an immunological response to one or more milk proteins. CMPA may be IgE mediated or Non-IgE mediated. It is one of the most frequent causes of food allergies in young children with an estimated prevalence between 1.9% and 4.9% in the first year of life.
CMPA has a good prognosis and cow milk is reintroduced in child diet. Natural history of CMPA shows heterogeneity and it is closely related to the clinical phenotype by which it was presented.
The timing and evaluation of developing tolerance is determined by clinical response to milk introduction.
When diagnosis of CMPA is confirmed, fresh pasteurized cow's milk can be used above 12 months of age in oral food challenge procedure, the starting dose should be lower than a dose that can induce a reaction and then increased step wise to 100ml, in children with mild to moderate reactions doses of 1ml, 3ml, 10ml, 30ml, and 100ml may be given at 30 minutes' intervals.
The milk ladder is an evidence-based plan to re-introduce milk products gradually and in stages for infants and children with mild to moderate cow's milk allergy, starting with food that contain only small amount of well-cooked milk and progressing towards uncooked dairy products and fresh milk. It's only started once child has been on a milk free diet for at least 6 months and they are completely well with no active eczema or gastro-intestinal symptoms.
Addition of baked- milk to the diet appears to accelerate the development of unheated-milk tolerance compared to strict avoidance, also its consumption is considered a form of immunotherapy with favorable safety, higher convenience, lower cost and less intensity when compared to oral immunotherapy. It's suggested to enhance the quality of life by removing unnecessary dietary restrictions and change the natural evaluation of milk allergy by promoting the development of tolerance to regular cow's milk.
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's enrollment of 116 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.
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Exclusion Criteria:
Patient with:
Patients with cow milk protein allergy after 6 month of elimination diet will receive direct milk antigen and will be followed up for 2 months for the development of any symptoms of milk intolerance
Dietary Supplement: Direct Milk antigen reintroduction
Patient with cow milk protein allergy after 6 month of elimination diet will be offered indirect milk antigen through a ladder starting by baked milk products and will be followed up for also for 2 months to detect any symptoms of intolerance.
Dietary Supplement: Milk ladder
Direct milk antigen re-introduction milk according to ESPGHAN guidelines
B: Milk ladder according to the iMAP guideline which are 6 weeks of gradual reintroduction starting with baked milk not direct antigen
Compare the frequency of tolerance to milk between the two groups
Questionnaire done to assess occurrence of following symptoms Vomiting, Hematemesis, Diarrhea (using BRISTOL scale), Constipation, Eczema, Skin rash, Perianal inflammation, weight loss in kilograms or failure to gain weight in kilograms, (Colic, Straining and marked Abdominal distension), and recurrent respiratory symptoms within two months of following up after milk reintroduction. If any of the previous items is present, then the patient is considered intolerant to milk. All items should be answered by (no) in order to consider the patient tolerant to milk
Time frame: intervention will be made six months of elimination diet, and follow up of 2 months later
Recording of overall percentage of milk tolerance after 6 months elimination diet
the same questionnaire used to assess tolerance to milk products. Also all answers should be answered by No, otherwise patient would still be considered intolerant.
Time frame: intervention will be made six months of elimination diet, and follow up of 2 months later
Plan to share: No
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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