Biomaterial Database

Safety of a New Amino Acid Formula in Infants Allergic to Cow's Milk and Intolerant to Hydrolysates. 2015

Christophe Dupont, and Nicolas Kalach, and Pascale Soulaines, and Elena Bradatan, and Alain Lachaux, and François Payot, and Frédéric De Blay, and Lydie Guénard-Bilbault, and Riad Hatahet, and Sandra Mulier, and Nathalie Kapel, and Anne-Judith Waligora-Dupriet, and Marie-José Butel

*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.

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.

UI	MeSH Term	Description	Entries
D007223	Infant	A child between 1 and 23 months of age.	Infants
D007227	Infant Nutritional Physiological Phenomena	Nutritional physiology of children from birth to 2 years of age.	Infant Nutrition Physiology,Nutrition Physiology, Infant,Complementary Feeding,Infant Nutritional Physiological Phenomenon,Infant Nutritional Physiology,Supplementary Feeding,Complementary Feedings,Feeding, Complementary,Feeding, Supplementary,Feedings, Complementary,Feedings, Supplementary,Nutritional Physiology, Infant,Physiology, Infant Nutrition,Physiology, Infant Nutritional,Supplementary Feedings
D008297	Male		Males
D010368	Pectins	High molecular weight polysaccharides present in the cell walls of all plants. Pectins cement cell walls together. They are used as emulsifiers and stabilizers in the food industry. They have been tried for a variety of therapeutic uses including as antidiarrheals, where they are now generally considered ineffective, and in the treatment of hypercholesterolemia.	Calcium Pectinate,Methoxy Pectin,Methoxylpectin,Methoxypectin,Pectin,Pectinic Acid,Zinc Pectinate,Pectin, Methoxy,Pectinate, Calcium,Pectinate, Zinc
D011492	Protein Hydrolysates	A complex mixture of OLIGOPEPTIDES, PEPTIDES, and free AMINO ACIDS that are produced by partial or extensive hydrolysis.	Protein Hydrolysate,Hydrolysate, Protein,Hydrolysates, Protein
D002241	Carbohydrates	A class of organic compounds composed of carbon, hydrogen, and oxygen in a ratio of Cn(H2O)n. The largest class of organic compounds, including STARCH; GLYCOGEN; CELLULOSE; POLYSACCHARIDES; and simple MONOSACCHARIDES.	Carbohydrate
D002657	Child Development	The continuous sequential physiological and psychological maturing of an individual from birth up to but not including ADOLESCENCE.	Infant Development,Development, Child,Development, Infant
D004041	Dietary Fats	Fats present in food, especially in animal products such as meat, meat products, butter, ghee. They are present in lower amounts in nuts, seeds, and avocados.	Fats, Dietary,Dietary Fat,Fat, Dietary
D004043	Dietary Fiber	The remnants of plant cell walls that are resistant to digestion by the alimentary enzymes of man. It comprises various polysaccharides and lignins.	Fiber, Dietary,Roughage,Wheat Bran,Bran, Wheat,Brans, Wheat,Dietary Fibers,Fibers, Dietary,Roughages,Wheat Brans
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked