Dataset Information
Tolerability of a new amino acid-based formula for children with IgE-mediated cow's milk allergy.
Ontology highlight
ABSTRACT: Background
Amino acid-based formula (AAF) is a relevant dietary strategy for paediatric patients affected by cow's milk allergy (CMA). The present study was designed to evaluate the hypoallergenicity of a new AAF in children with immunoglobulin (Ig)E-mediated CMA.Methods
According to the criteria provided by the American Academy of Pediatrics Subcommittee on Nutrition and Allergic Diseases, we designed a prospective trial in CMA children (aged 1-36 months) aimed to demonstrate the hypoallergenicity of the new AAF in 90% of subjects with 95% confidence during the double-blind, placebo-controlled challenge (DBPCFC). A skin prick test (SPT) with the new AAF was also performed.Results
Twenty-nine children [all Caucasian, 55.2% male, mean age (±SD) 16.9 ± 5.7 months] were enrolled. The SPT and the DBPCFC with the new AAF were negative in all study subjects.Conclusions
The study results support the hypoallergenicity of the new AAF. This formula could be considered an additional dietary option for non-breastfed children affected by CMA.Trial registration
The trial was registered in the ClinicalTrials.gov Protocol Registration System (ID number: NCT03909113 ).
SUBMITTER: Nocerino R
PROVIDER: S-EPMC8254988 | biostudies-literature | 2021 Jul
REPOSITORIES: biostudies-literature
Publications
Tolerability of a new amino acid-based formula for children with IgE-mediated cow's milk allergy.
Italian journal of pediatrics 20210703 1
<h4>Background</h4>Amino acid-based formula (AAF) is a relevant dietary strategy for paediatric patients affected by cow's milk allergy (CMA). The present study was designed to evaluate the hypoallergenicity of a new AAF in children with immunoglobulin (Ig)E-mediated CMA.<h4>Methods</h4>According to the criteria provided by the American Academy of Pediatrics Subcommittee on Nutrition and Allergic Diseases, we designed a prospective trial in CMA children (aged 1-36 months) aimed to demonstrate th ...[more]