Erschienen in:
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
verfasst von:
Christophe Dupont, Nicolas Kalach, Pascale Soulaines, Elena Bradatan, Alain Lachaux, François Payot, Frédéric de Blay, Lydie Guénard-Bilbault, Riad Hatahet, Sandra Mulier
Erschienen in:
Pediatric Drugs
|
Ausgabe 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.