The Effect of Baked Milk on Cow's Milk Allergy
Condition: Cow's Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the effect of baked milk in immunotherapy of cow's milk allergy.
    

Detailed description: 
      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.
    

Intervention name(s): Baked Milk
Intervention type(s): Dietary Supplement
Intervention description(s): The patients in case group will be received baked milk daily in the form of muffin(30 cc milk (equal to 1/3 of milk's proteins) heated in 350 F or 180 C for 30 mints) for 6 months. They will be visited weekly in the first month and every 2 weeks in other 5 months. At the end of the 6 months, the patients will undergo oral food challenge by 30 grams baked cheese in the form of pizza cheese. If the test will be negative, they will receive pizza cheese 4 or 7 days per week for other 6 months. The patients will be followed every 2 weeks during this period.
Skin prick test and serum IgE levels will be done at the beginning of the study, at 6 and 12 months. IgG4, being specific for milk allergens, will also measured at the beginning and at 12 months of the study.
Other intervention name(s): muffin; pizza cheese; baked milk products
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment