title: Safety of a New Amino Acid Formula in Infants Allergic to Cow's Milk and Intolerant to Hydrolysates.
abstract: OBJECTIVE
  Amino acid-based formulas (AAFs) are recommended for children with cow's-milk allergy (CMA) failing to respond to extensively hydrolysed formulas (eHFs). We evaluated the effects of a new thickened AAF (TAAF, Novalac), containing a pectin-based thickener, and a reference AAF (RAAF, Neocate) on allergy symptoms and safety, through blood biochemistry analysis and growth.
  
  
  METHODS
  Infants (ages < 18 months) with CMA symptoms failing to respond to eHFs were randomised in a double-blind manner to receive TAAF or RAAF for 3 months. All of the infants were then fed TAAF for 3 additional months. Paediatric visits occurred at 1, 3, and 6 months. Blood samples were collected at inclusion and 3 months.
  
  
  RESULTS
  Results at 1 month were previously described. The 75 infants with proven CMA and eHF intolerance tolerated their allocated formula. At 3 months, the dominant allergic symptom had disappeared in 76.2% of the infants with TAAF and in 51.5% of the infants with RAAF (P = 0.026). The Scoring Atopic Dermatitis Index significantly improved more with TAAF than with RAAF (-27.3 ± 2.3 vs -20.8 ± 2.2, P = 0.048). Of the infants, 92.9% had normal stools (soft or formed consistency) with TAAF vs 75.8% with RAAF (P = 0.051). More infants in TAAF group had better quality of nighttime sleep (P = 0.036) and low frequency of irritability signs (P < 0.001). With both formulas, all of the biochemical parameters were within normal ranges. There were no differences between the 2 groups in any of the anthropometric z scores.
  
  
  CONCLUSIONS
  The new TAAF was tolerated by all of the infants with CMA and intolerance to eHFs. Anthropometric and clinical data showed that both formulas were safe.
authors.affiliation: *Pediatric Gastroenterology, Hepatology and Nutrition Department, Necker Children's Hospital, Paris, France †Saint Antoine Clinics of Pediatrics, Saint Vincent de Paul Hospital, Groupement des Hôpitaux de l'Institut Catholique, Lille, France ‡Department of Pediatrics, Regional Hospital, Namur, Belgium §Gastroenterology, Hepatology and Nutrition Unit, University and Pediatric Hospital of Lyon, Lyon, France ||Pulmonology and Allergology Department, Regional University Hospital, Strasbourg, France ¶private allergy medical practice, Illkirch-Graffenstaden #private allergy medical practice, Forbach, France **Allergology Department, Queen Fabiola Children's University Hospital, Brussels, Belgium ††Intestinal Ecosystem, Probiotics, Antibiotics (EA4065), Sorbonne Paris Cité, DHU Risks in Pregnancy, Paris Descartes University, Paris, France.
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
authors.forename: Nathalie
authors.initials: N
authors.lastname: Kapel
authors.forename: Anne-Judith
authors.initials: AJ
authors.lastname: Waligora-Dupriet
authors.forename: Marie-José
authors.initials: MJ
authors.lastname: Butel
mesh_terms: D000596:Amino Acids / Q000008:administration & dosage* / Q000009:adverse effects / Q000032:analysis / Q000737:chemistry; D001530:Belgium; D015415:Biomarkers / Q000032:analysis; D002241:Carbohydrates / Q000009:adverse effects / Q000737:chemistry; D002657:Child Development; D015331:Cohort Studies; D004041:Dietary Fats / Q000009:adverse effects; D004043:Dietary Fiber / Q000008:administration & dosage / Q000032:analysis; D004311:Double-Blind Method; D047208:Eosinophil-Derived Neurotoxin / Q000032:analysis; D005243:Feces / Q000737:chemistry / Q000382:microbiology; D005260:Female; D005602:France; D000069196:Gastrointestinal Microbiome / Q000276:immunology; D006801:Humans; D007223:Infant; D018730:Infant Behavior; D041943:Infant Formula / Q000737:chemistry; D007227:Infant Nutritional Physiological Phenomena; D008297:Male; D016269:Milk Hypersensitivity / Q000178:diet therapy* / Q000276:immunology / Q000382:microbiology / Q000503:physiopathology; D010368:Pectins / Q000737:chemistry; D011492:Protein Hydrolysates / Q000009:adverse effects*; D014783:Viscosity
chemical_list: D000596:Amino Acids; D015415:Biomarkers; D002241:Carbohydrates; D004041:Dietary Fats; D004043:Dietary Fiber; C076533:Neocate; D011492:Protein Hydrolysates; D010368:Pectins; D047208:Eosinophil-Derived Neurotoxin; C479221:RNASE2 protein, human