Cow's Milk Allergy Clinical Trial
Official title:
Efficacy of Baked Milk in Accelerating Resolution of Cow's Milk Allergy
To investigate the effect of baked milk in immunotherapy of cow's milk allergy.
Food allergy, as an immune based hypersensitivity reaction, is estimated to be about 6% in
young children and 3-4% in adults [1, 2]. Its pathophysiology is defined trough both IgE and
non-IgE mediated mechanisms, which lead to skin, gastrointestinal, respiratory and systemic
manifestations [1]. This type of allergy is mostly seen trough the first year of life. One
study showed that about 2.5% of the neonates show allergy to cow's milk [3].
Most of food allergens are cow's milk, chicken egg, corn, soya, peanut, dried fruits, and
fishes. Among them, cow's milk is considered to be the most common one, specifically, among
the children [1, 2].
This allergen consists of about 20 proteins which all can induce immune system to produce
antibodies. The two major protein components of milk are casein and whey. About 76 to 86% of
it is casein, which is responsible for the IgE mediated immune response. On the other hand,
whey, which is composed of alpha-lactalbumin, beta-lactoglobulin, and albumin, is mostly
induced systemic allergic reactions [4].
Boiling the milk at 95 c for 20 minutes can damage some whey's protein components; however,
it cannot damage the major milk's allergens. Pasteurization is also shown to have no effect
on these allergens [5].
It was shown that IgE mediated mechanisms are involved in lifelong cow's milk allergy. In
spite of that, about 50% of children up to 1 year old and 85% up to 3 years old develop by
tolerance to milk's allergen [6].
Oral food challenge (OFC) test confirming by skin prick test and serum IgE levels is one of
the most sensitive tools for diagnosis of food allergy. It was shown to have sensitivity
about 95 % and specificity about 50%[7].
Comparing baked milk and non-heated milk allergy was shown that ones with allergy to baked
milk have more chance of developing anaphylactic reactions. Some studies on patients who can
tolerate baked milk suggest that adding these products to the daily diet of sensitive
children can improve tolerance to cow's milk [8, 9]. On the other hand, another study in
Australia showed that phenotype is the strongest predictor of tolerance development and
altered allergen such as baked milk does not have significant effect in this process [10].
Thus, according to the controversies on effect of baked milk in immunotherapy of cow's milk
allergy as well as the necessity of developing a safe method of milk's allergy due to high
risk of anaphylactic reactions to milk's products in patients, it seems to be essential to
perform a study assessing the possibility of tolerance induction by baked milk in cow's milk
allergic children.
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