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

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

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.

Study Overview

• Status: Unknown
• Conditions: Cow's Milk Allergy

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • University of Naples Federico II
    • Contact: Roberto Berni Canani; Phone Number: 0817462680

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with cow's milk allergy diagnosed by family pediatrician operating in Italy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cow's milk allergy; Subjcets with a sure diagnosis of cow'a milk allergy on exclusion diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): November 1, 2014

Study Registration Dates

• First Submitted: May 14, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Estimate): May 22, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: 05/14