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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02144428
Enrollment
300
Registered
2014-05-22
Start date
2011-04-30
Completion date
2014-11-30
Last updated
2014-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow's Milk Allergy

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.

Interventions

None listed

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 36 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of subjects with cow's milk allergy tolerant substitutive formulasAt diagnosis and for at least 1 months after the diagnosisSafety and tolerability of substitutive formulas

Countries

Italy

Contacts

Primary ContactRoberto Berni Canani, MD, PhD
0817462680

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026