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.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  Both AAFs were well tolerated by infants with CMPA and eHF intolerance and ensured appropriate growth, with the TAAF providing additional comfort.
authors.affiliation: Pediatric Gastroenterology, Hepatology and Nutrition Department, Necker Children's Hospital, 149, rue de Sèvres, 75015, Paris, France, christophe.dupont@nck.aphp.fr.
authors.forename: Christophe
authors.initials: C
authors.lastname: Dupont
authors.forename: Nicolas
authors.initials: N
authors.lastname: Kalach
authors.forename: Pascale
authors.initials: P
authors.lastname: Soulaines
authors.forename: Elena
authors.initials: E
authors.lastname: Bradatan
authors.forename: Alain
authors.initials: A
authors.lastname: Lachaux
authors.forename: François
authors.initials: F
authors.lastname: Payot
authors.forename: Frédéric
authors.initials: F
authors.lastname: de Blay
authors.forename: Lydie
authors.initials: L
authors.lastname: Guénard-Bilbault
authors.forename: Riad
authors.initials: R
authors.lastname: Hatahet
authors.forename: Sandra
authors.initials: S
authors.lastname: Mulier
mesh_terms: D000596:Amino Acids / Q000008:administration & dosage* / Q000009:adverse effects; D000818:Animals; D002241:Carbohydrates / Q000008:administration & dosage* / Q000009:adverse effects; D002417:Cattle; D004041:Dietary Fats / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000008:administration & dosage*; D008297:Male; D016269:Milk Hypersensitivity / Q000628:therapy*; D011492:Protein Hydrolysates / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000596:Amino Acids; D002241:Carbohydrates; D004041:Dietary Fats; C076533:Neocate; D011492:Protein Hydrolysates