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1.
J Pediatr Gastroenterol Nutr ; 61(4): 456-63, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25844709

RESUMO

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 ±â€Š2.3 vs -20.8 ±â€Š2.2, 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.


Assuntos
Aminoácidos/administração & dosagem , Desenvolvimento Infantil , Comportamento do Lactente , Fórmulas Infantis , Fenômenos Fisiológicos da Nutrição do Lactente , Hipersensibilidade a Leite/dietoterapia , Hidrolisados de Proteína/efeitos adversos , Aminoácidos/efeitos adversos , Aminoácidos/análise , Aminoácidos/química , Bélgica , Biomarcadores/análise , Carboidratos/efeitos adversos , Carboidratos/química , Estudos de Coortes , Gorduras na Dieta/efeitos adversos , Fibras na Dieta/administração & dosagem , Fibras na Dieta/análise , Método Duplo-Cego , Neurotoxina Derivada de Eosinófilo/análise , Fezes/química , Fezes/microbiologia , Feminino , França , Microbioma Gastrointestinal/imunologia , Humanos , Lactente , Fórmulas Infantis/química , Masculino , Hipersensibilidade a Leite/imunologia , Hipersensibilidade a Leite/microbiologia , Hipersensibilidade a Leite/fisiopatologia , Pectinas/química , Viscosidade
2.
Paediatr Drugs ; 16(6): 513-22, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25446768

RESUMO

INTRODUCTION: 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. CONCLUSION: Both AAFs were well tolerated by infants with CMPA and eHF intolerance and ensured appropriate growth, with the TAAF providing additional comfort.


Assuntos
Aminoácidos/administração & dosagem , Carboidratos/administração & dosagem , Gorduras na Dieta/administração & dosagem , Fórmulas Infantis/administração & dosagem , Hipersensibilidade a Leite/terapia , Hidrolisados de Proteína/administração & dosagem , Aminoácidos/efeitos adversos , Animais , Carboidratos/efeitos adversos , Bovinos , Gorduras na Dieta/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Lactente , Masculino , Hidrolisados de Proteína/efeitos adversos
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