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

NCT02144428 | Unknown

• 1 other identifier: 05/14
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Cow's milk allergy

Subjcets with a sure diagnosis of cow'a milk allergy on exclusion diet

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• subjects with a cow's milk allergy
• age between 0 to 36 months

You may not qualify if:

• 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,

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Roberto Berni Canani, MD, PhD

CONTACT

0817462680

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 22, 2014
• Study Start: April 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

IT (1)