Clinical Trial: The Effect of Baked Milk on Cow's Milk Allergy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Efficacy of Baked Milk in Accelerating Resolution of Cow's Milk Allergy
Brief Summary: To investigate the effect of baked milk in immunotherapy of cow's milk allergy.
Detailed Summary:
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].
Sponsor: Hossein EsmaielzadehCurrent Primary Outcome: Tolerance to cow's milk assessed by oral food challenge test [ Time Frame: 1 month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Tolerance to cow's milk by measuring serum specific IgE levels [ Time Frame: 1 month ]
- Tolerance to cow's milk using skin prick test [ Time Frame: 1 month ]
- Tolerance to cow's milk by measuring serum IgG4 [ Time Frame: 1 month ]
Original Secondary Outcome: Same as current
Information By: Shiraz University of Medical Sciences
Dates:
Date Received: April 5, 2016
Date Started: September 2015
Date Completion: March 2017
Last Updated: April 14, 2016
Last Verified: April 2016
