title: Normal Growth of Healthy Infants Born from HIV+ Mothers Fed a Reduced Protein Infant Formula Containing the Prebiotics Galacto-Oligosaccharides and Fructo-Oligosaccharides: A Randomized Controlled Trial.
abstract: OBJECTIVE
  The aim of the current study was to evaluate the safety of a new reduced protein (2.1 g/100 kcal) infant formula containing 4 g/L of 90% galacto-oligosaccharides (GOS) and 10% fructo-oligosaccharides (FOS).
  
  
  METHODS
  Healthy term infants from Brazil were enrolled. Those born to human immunodeficiency virus (HIV)-positive mothers were randomized to a test (n = 65) or control (n = 63) formula group. Infants born to HIV-negative mothers were either exclusively breast-fed (n = 79) or received a mixed diet (breast milk and test formula, n = 65). Between 2 weeks and 4 months of age, infants were exclusively fed according to their assigned group. Anthropometric measurements were taken at baseline, 1, 2, 3, 4, 6, 8, 10, and 12 months. Digestive tolerance was evaluated during the first 4 months. The primary outcome was mean daily weight gain between 2 weeks and 4 months in the test formula and breast-fed groups.
  
  
  RESULTS
  Data from all infants (N = 272) were used in the intention-to-treat (ITT) analysis and data from 230 infants were used in the per-protocol (PP) analysis. The difference in mean daily weight gain between 2 weeks and 4 months in the test formula and breast-fed groups was 1.257 g/day (one-sided 95% confidence interval [CI]: -0.705 to inf, P < 0.001) in the PP analysis, showing that the lower bound of the 95% CI was above the -3.0 g/day non-inferiority margin. Results were similar in the ITT analysis. Symptoms of digestive tolerance and frequency of adverse events were similar in the two groups.
  
  
  CONCLUSIONS
  The formula containing 2.1 g/100 kcal protein and GOS and FOS was safe and tolerated well.
authors: Pediatrics, Federal University of Bahia School of Medicine, Salvador de Bahia, Brazil.
authors: Hugo
authors: H
authors: da Costa Ribeiro
authors: Fima Lifshitz Research Center, University Hospital Complex at Federal University of Bahia, Salvador de Bahia, Brazil.
authors: Tereza Cristina Medrado
authors: TC
authors: Ribeiro
authors: Pediatrics, Federal University of Bahia School of Medicine, Salvador de Bahia, Brazil.
authors: Angela Peixoto
authors: AP
authors: de Mattos
authors: Fima Lifshitz Research Center, University Hospital Complex at Federal University of Bahia, Salvador de Bahia, Brazil.
authors: Mariana
authors: M
authors: Pontes
authors: Faculdade de Medicina do ABC, Santo André, de São Paulo, Brazil.
authors: Roseli Oselka Saccardo
authors: RO
authors: Sarni
authors: Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.
authors: Maria Letícia Santos
authors: ML
authors: Cruz
authors: Nutrology Department, University of Ribeirão Preto, Ribeirão Preto, Brazil.
authors: Carlos Alberto
authors: CA
authors: Nogueira-de-Almeida
authors: Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto de São Paulo, Brazil.
authors: Marisa M
authors: MM
authors: Mussi-Pinhata
authors: Pediatrics, Federal University of Minas Gerais School of Medicine, Belo Horizontede Minas Gerais, Brazil.
authors: Rocksane
authors: R
authors: de Carvalho Norton
authors: Nestlé Clinical Development Unit, Vevey, Switzerland.
authors: Philippe
authors: P
authors: Steenhout
keywords: fructo-oligosaccharides; galacto-oligosaccharides; infant formula; safety; weight gain