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

Cow's Milk Allergy Clinical Trial

Official title:

DETERMINATION OF HYPOALLERGENICITY TO SUBSTITUTIVE FORMULAS IN CHILDREN WITH COW'S MILK ALLERGY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02144428
• Other study ID #: 05/14
• Status: Recruiting
• Phase: N/A
• First received: May 14, 2014
• Last updated: May 19, 2014
• Start date: April 2011
• Est. completion date: November 2014

Study information

• Verified date: May 2014
• Source: Federico II University
• Contact: Roberto Berni Canani, MD, PhD
• Phone: 0817462680
• Is FDA regulated: No
• Health authority: Italy: Ethic Commitee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 36 Months

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cow's Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with cow's milk allergy tolerant substitutive formulas	Safety and tolerability of substitutive formulas	At diagnosis and for at least 1 months after the diagnosis	No