Hypoallergenicity To Substitutive Formulas In Children With Cow's Milk Allergy

• Conditions: Cow's Milk Allergy

• Registration Number: NCT02144428
• Lead Sponsor: Federico II University

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 Description

Not available

Study Timeline

• Study Start: 2011-04
• Status Verified: 2014-05
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-19
• Last Update Submitted: 2014-05-19
• Study First Posted: 2014-05-22
• Last Update Posted: 2014-05-22
• Primary Completion: 2014-11
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of subjects with cow's milk allergy tolerant substitutive formulas	At diagnosis and for at least 1 months after the diagnosis	Safety and tolerability of substitutive formulas

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy