Research Trial for Cow’s Milk Allergy in Children (3 Months)

Non-IgE mediated food allergies are caused by a reaction involving other components of the immune system apart from Immunoglobulin E antibodies. The reactions do not appear immediately after the ingestion of the food and usually relate to reactions in the gastrointestinal tract. For this trial, boys and girls aged 1 month to 5 years old with a history of symptoms consistent with non-IgE mediated cow’s milk allergy, may qualify to participate. Children must have two or more gastrointestinal symptoms (vomiting, diarrhea, persistent distress/colic, regurgitation, constipation) that lasted at least 1 week within 1 month prior to screening, OR blood in the stool. Children with any type of diet containing regular cow’s milk protein (e.g. cow’s milk consumption, cow’s milk partial elimination, partially hydrolyzed milk) within 1 month prior to screening, will be considered.

Participants will receive an atopy patch test (APT) for diagnostic use containing 2 patches (active and control) applied to the back for 48 hours. Study product and study-related procedures will be provided at no cost. Reimbursement for study-related expenses will also be provided.

For disease group participants, participation will last up to 3 months and involve about 7 visits to the study centre, plus some phone visits.

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Cow's Milk Allergy
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Why Take Part In a Clinical Study?

Regulatory agencies like Health Canada, Australia's Therapeutic Goods Administration and the FDA require that Clinical Research Trials be conducted in order to develop new treatments, preventions and devices for diseases or conditions. Clinical Research Trials are also referred to as Clinical Studies or Clinical Trials. read more