Cow's Milk Allergy | Hypoallergenicity To Substitutive Formulas In Children With Cow's Milk Allergy
Cow's Milk Allergy research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - subjects with a cow's milk allergy - age between 0 to 36 months Exclusion Criteria: - age more than 36 months - eosinophilic disorders of the gastrointestinal tract, - food protein induced enterocolitic syndrome, - concomitant chronic systemic diseases, - congenital cardiac defects, - active tuberculosis, - autoimmune diseases, - immunodeficiency, - chronic inflammatory bowel diseases, - celiac disease, - cystic fibrosis, - metabolic diseases, - lactose intolerance, - malignancy, - chronic pulmonary diseases, - malformations of the gastrointestinal tract.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Cow's Milk Allergy
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Cow's milk allergySubjcets with a sure diagnosis of cow'a milk allergy on exclusion diet
Start Date: April 2011
Completed Date: November 2014
Primary Outcome: Number of subjects with cow's milk allergy tolerant substitutive formulas
Study sponsors, principal investigator, and references
Lead Sponsor: Federico II University