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Pediatric Drugs
Published in: Pediatric Drugs 6/2014

01-12-2014 | Original Research Article

A Thickened Amino-Acid Formula in Infants with Cow’s Milk Allergy Failing to Respond to Protein Hydrolysate Formulas: A Randomized Double-Blind Trial

Authors: Christophe Dupont, Nicolas Kalach, Pascale Soulaines, Elena Bradatan, Alain Lachaux, François Payot, Frédéric de Blay, Lydie Guénard-Bilbault, Riad Hatahet, Sandra Mulier

Published in: Pediatric Drugs | Issue 6/2014

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Abstract

Introduction

Amino-acid-based formulas (AAFs) are recommended for children with cow’s milk protein allergy (CMPA) failing to respond to extensively hydrolyzed formulas (eHFs).

Objective

This study aimed to assess the tolerance/hypoallergenicity and efficacy of a thickened AAF (TAAF) in these infants.

Methods

This multicenter, double-blind, randomized controlled trial (NCT01940068) compared 3-month feeding with a pectin-based TAAF (Novalac®, United Pharmaceuticals, Paris, France) and a commercially available “reference” AAF (RAAF; Neocate®, Nutricia, Germany) in infants aged <18 months with CMPA and persistent allergy symptoms with eHF feeding. Reported here are the results of an interim analysis after 1 month of feeding.

Results

Of the 86 infants randomized, CMPA with eHF intolerance was confirmed in 75 infants; all of them tolerated the allocated AAFs. The major allergic symptom disappeared within 1 month in 61.9 and 51.5 % and regurgitations disappeared in 66.7 and 42.3 % of infants who received TAAF and RAAF, respectively. Infants had significantly more normal stools (soft or formed consistency) with the TAAF (90.5 vs. 66.7 %; p = 0.011). From baseline, daily family life significantly improved with both AAFs: crying time decreased by 97.3 (p < 0.001) and 28.6 min (p = 0.014) and sleeping time increased by 64.6 (p = 0.009) and 29.0 min with TAAF and RAAF, respectively. At day 30, weight and body mass index z-score gains were 0.1 and 0.2 with TAAF and 0.2 and 0.0 with RAAF.

Conclusion

Both AAFs were well tolerated by infants with CMPA and eHF intolerance and ensured appropriate growth, with the TAAF providing additional comfort.
Appendix
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Metadata
Title
A Thickened Amino-Acid Formula in Infants with Cow’s Milk Allergy Failing to Respond to Protein Hydrolysate Formulas: A Randomized Double-Blind Trial
Authors
Christophe Dupont
Nicolas Kalach
Pascale Soulaines
Elena Bradatan
Alain Lachaux
François Payot
Frédéric de Blay
Lydie Guénard-Bilbault
Riad Hatahet
Sandra Mulier
Publication date
01-12-2014
Publisher
Springer International Publishing
Published in
Pediatric Drugs / Issue 6/2014
Print ISSN: 1174-5878
Electronic ISSN: 1179-2019
DOI
https://doi.org/10.1007/s40272-014-0097-x

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