Christophe Dupont1, Nicolas Kalach, Pascale Soulaines, Elena Bradatan, Alain Lachaux, François Payot, Frédéric De Blay, Lydie Guénard-Bilbault, Riad Hatahet, Sandra Mulier, Nathalie Kapel, Anne-Judith Waligora-Dupriet, Marie-José Butel. 1. *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.
Abstract
OBJECTIVES: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.
RCT Entities:
OBJECTIVES: Amino acid-based formulas (AAFs) are recommended for children with cow's-milkallergy (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: Vincenzo Fierro; Rocco L Valluzzi; Claudia Banzato; Ma A Plaza; Montserrat Bosque; Marcel Íbero; Luis A Z Echeverría; Maurizio Mennini; Lamia Dahdah; Roser de Castellar; Gloria Tort; Jesus Jiménez Journal: Immun Inflamm Dis Date: 2020-02-28
Authors: Rita Nocerino; Serena Coppola; Laura Carucci; Lorella Paparo; Anna Fiorenza De Giovanni Di Santa Severina; Roberto Berni Canani Journal: Front Allergy Date: 2022-09-05
Authors: Yvan Vandenplas; Christophe Dupont; Philippe Eigenmann; Ralf G Heine; Arne Høst; Anette Järvi; Mikael Kuitunen; Rajat Mukherjee; Carmen Ribes-Koninckx; Hania Szajewska; Andrea von Berg; Zheng-Yan Zhao Journal: Pediatr Gastroenterol Hepatol Nutr Date: 2021-07-05