Randomized Controlled Trial
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Aug 26, 2019; 7(16): 2256-2268
Published online Aug 26, 2019. doi: 10.12998/wjcc.v7.i16.2256
Hypoallergenicity of a thickened hydrolyzed formula in children with cow’s milk allergy
Danilo Rossetti, Salvatore Cucchiara, Alessandra Morace, Beatrice Leter, Salvatore Oliva
Danilo Rossetti, Salvatore Cucchiara, Alessandra Morace, Beatrice Leter, Salvatore Oliva, Department of Pediatrics, Sapienza University of Rome, Rome 00161, Italy
Author contributions: All authors conceptualized and designed the study; The authors all participated in the recruitment and follow-up of patients and were involved in data collection; the authors critically reviewed and approved the final manuscript.
Institutional review board statement: Our Institutional Review Board approved the study.
Informed consent statement: The parents of all patients gave informed consent.
Conflict-of-interest statement: The authors have no competing interests to declare.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Danilo Rossetti, MD, Academic Fellow, Doctor, Department of Pediatrics, Sapienza University of Rome, Viale Regina Elena 324, Rome 00161, Italy. danilo.rossetti@uniroma1.it
Telephone: +39-64-9979326 Fax: 39-64-9979325
Received: March 6, 2019
Peer-review started: March 6, 2019
First decision: May 10, 2019
Revised: July 18, 2019
Accepted: July 27, 2019
Article in press: July 27, 2019
Published online: August 26, 2019
Processing time: 173 Days and 7 Hours
Core Tip

Core tip: The hypoallergenicity of the new tested formula as the primary criterion was rigorously confirmed through a properly designed double-blind placebo-controlled food challenge (DBPCFC) in children with a diagnosis of cow’s milk allergy (CMA) that was confirmed by a DBPCFC, the gold standard diagnostic procedure for food allergies. The subsequent 3-mo open exclusive feeding with the tested formula showed that the formula was still well tolerated by the 29 children with CMA included, their growth was adequate, and parents and the investigator were very satisfied with the effect of the formula.