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Randomized Controlled Trial
. 2021 Jul 3;47(1):151.
doi: 10.1186/s13052-021-01096-3.

Tolerability of a new amino acid-based formula for children with IgE-mediated cow's milk allergy

Rita Nocerino  1   2 , Carmen Di Scala  1   2 , Serena Coppola  1   2 , Veronica Giglio  1   2 , Laura Carucci  1   2 , Linda Cosenza  1   2 , Luana Voto  1 , Anna Maria Iannicelli  1 , Anna Luzzetti  1 , Roberto Berni Canani  3   4   5   6
Affiliations
Randomized Controlled Trial

Tolerability of a new amino acid-based formula for children with IgE-mediated cow's milk allergy

Rita Nocerino et al. Ital J Pediatr. .

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 ).

Keywords: Diet therapy; Food allergy; Hypoallergenic formula; Infant formula.

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Conflict of interest statement

The authors have no conflicts of interest that are directly relevant to the content of this paper, which remains their sole responsibility.

Figures

Fig. 1
Fig. 1
The design of the study
Fig. 2
Fig. 2
Flow of the children through the study
See this image and copyright information in PMC

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