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

NCT ID: NCT02144428

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-11-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cow's milk allergy

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

No interventions assigned to this group

Eligibility Criteria

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.

• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Naples Federico II

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberto Berni Canani, MD, PhD

Role: CONTACT

0817462680

Facility Contacts

Roberto Berni Canani

Role: primary

0817462680

Other Identifiers

05/14

Identifier Type: -

Identifier Source: org_study_id