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J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):456-63. doi: 10.1097/MPG.0000000000000803.

Safety of a New Amino Acid Formula in Infants Allergic to Cow's Milk and Intolerant to Hydrolysates.

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*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.



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.


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 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.


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.


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