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BMC Pediatrics
Published in: BMC Pediatrics 1/2013

Open Access 01-12-2013 | Research article

Tolerance to a new free amino acid-based formula in children with IgE or non-IgE-mediated cow’s milk allergy: a randomized controlled clinical trial

Authors: Roberto Berni Canani, Rita Nocerino, Ludovica Leone, Margherita Di Costanzo, Gianluca Terrin, Annalisa Passariello, Linda Cosenza, Riccardo Troncone

Published in: BMC Pediatrics | Issue 1/2013

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Abstract

Background

Amino acid-based formulas (Aaf) are increasingly used in children with cow’s milk allergy (CMA). To be labeled hypoallergenic these formulas must demonstrate in clinical studies that they don’t provoke reactions in 90% of subjects with confirmed CMA with 95% confidence when given in prospective randomized, double-blind, placebo-controlled challenge (DBPCFC) trials. The majority of available safety data on Aaf derived from patients with IgE-mediated CMA. Considering substantial differences in the immunologic mechanism and clinical presentation of non-IgE-mediated CMA it’s important to investigate the hypoallergenicity of these formulas also in these patients. We prospectively assessed the tolerance to a new commercially available Aaf in children affected by IgE- or non-IgE-mediated CMA.

Methods

Consecutive patients affected by IgE- or non-IgE-mediated CMA, aged ≤ 4 years, were enrolled. DBPCFC was carried out with increasing doses of the new Aaf (Sineall, Humana, Milan, Italy), using validated Aaf as placebo. Faecal concentrations of calprotectin (FC) and eosinophilic cationic protein (ECP) were monitored.

Results

Sixty patients (44 male, 73.3%, median age 37, 95%CI 34.5–39.6 months, IgE-mediated CMA 29, 48.3%) were enrolled. At the diagnosis clinical symptoms were gastrointestinal (46.6%), cutaneous (36.6%), respiratory (23.3%), and systemic (10.0%). After DBPCFC with the new Aaf, no patient presented early or delayed clinical reactions. Faecal concentration of calprotectin and of ECP remained stable after the exposure to the new Aaf.

Conclusions

The new Aaf is well tolerated in children with IgE- or non-IgE-mediated CMA, and it could be used as a safe dietotherapy regimen for children with this condition.

Trial registration

The trial was registered in the ClinicalTrials.gov Protocol Registration System (ID number: NCT01622426).
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Metadata
Title
Tolerance to a new free amino acid-based formula in children with IgE or non-IgE-mediated cow’s milk allergy: a randomized controlled clinical trial
Authors
Roberto Berni Canani
Rita Nocerino
Ludovica Leone
Margherita Di Costanzo
Gianluca Terrin
Annalisa Passariello
Linda Cosenza
Riccardo Troncone
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Pediatrics / Issue 1/2013
Electronic ISSN: 1471-2431
DOI
https://doi.org/10.1186/1471-2431-13-24

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