Clinical Trial: Hypoallergenicity To Substitutive Formulas In Children With Cow's Milk Allergy
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational
Official Title: DETERMINATION OF HYPOALLERGENICITY TO SUBSTITUTIVE FORMULAS IN CHILDREN WITH COW'S MILK ALLERGY
Brief Summary: The management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. In the absence of an alternative to cow's milk, the management of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate formulas. Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most children with cow's milk allergy, are still liable to contain residual peptides, and hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus, specific product allergenicity must be addressed on an individual basis before recommending a formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety and nutritional efficacy perspectives. These formulas have been proposed for subjects highly sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed formula and for children with multiple food allergies. In these conditions aminoacid based formulas are able to effectively cure allergic symptoms and to improve body growth.
Detailed Summary:
Sponsor: Federico II University
Current Primary Outcome: Number of subjects with cow's milk allergy tolerant substitutive formulas [ Time Frame: At diagnosis and for at least 1 months after the diagnosis ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Federico II University
Dates:
Date Received: May 14, 2014
Date Started: April 2011
Date Completion: November 2014
Last Updated: May 19, 2014
Last Verified: May 2014
