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da Costa Ribeiro H, Ribeiro TC, de Mattos AP, et al. 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. Clin Med Insights Pediatr. 2015;9:37-47doi: 10.4137/CMPed.S17841.
da Costa Ribeiro, H., Ribeiro, T. C., de Mattos, A. P., Pontes, M., Sarni, R. O., Cruz, M. L., Nogueira-de-Almeida, C. A., Mussi-Pinhata, M. M., de Carvalho Norton, R., & Steenhout, P. (2015). 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. Clinical medicine insights. Pediatrics, 937-47. https://doi.org/10.4137/CMPed.S17841
da Costa Ribeiro, Hugo, et al. "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." Clinical medicine insights. Pediatrics vol. 9 (2015): 37-47. doi: https://doi.org/10.4137/CMPed.S17841
da Costa Ribeiro H, Ribeiro TC, de Mattos AP, Pontes M, Sarni RO, Cruz ML, Nogueira-de-Almeida CA, Mussi-Pinhata MM, de Carvalho Norton R, Steenhout P. 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. Clin Med Insights Pediatr. 2015 Mar 09;9:37-47. doi: 10.4137/CMPed.S17841. eCollection 2015. PMID: 25788839; PMCID: PMC4357629.
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Clin Med Insights Pediatr. 2015 Mar 09;9:37-47. doi: 10.4137/CMPed.S17841. eCollection 2015.

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.

Clinical medicine insights. Pediatrics

Hugo da Costa Ribeiro, Tereza Cristina Medrado Ribeiro, Angela Peixoto de Mattos, Mariana Pontes, Roseli Oselka Saccardo Sarni, Maria Letícia Santos Cruz, Carlos Alberto Nogueira-de-Almeida, Marisa M Mussi-Pinhata, Rocksane de Carvalho Norton, Philippe Steenhout

Affiliations

  1. Pediatrics, Federal University of Bahia School of Medicine, Salvador de Bahia, Brazil.
  2. Fima Lifshitz Research Center, University Hospital Complex at Federal University of Bahia, Salvador de Bahia, Brazil.
  3. Faculdade de Medicina do ABC, Santo André, de São Paulo, Brazil.
  4. Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.
  5. Nutrology Department, University of Ribeirão Preto, Ribeirão Preto, Brazil.
  6. Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto de São Paulo, Brazil.
  7. Pediatrics, Federal University of Minas Gerais School of Medicine, Belo Horizontede Minas Gerais, Brazil.
  8. Nestlé Clinical Development Unit, Vevey, Switzerland.

PMID: 25788839 PMCID: PMC4357629 DOI: 10.4137/CMPed.S17841

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.

Keywords: fructo-oligosaccharides; galacto-oligosaccharides; infant formula; safety; weight gain

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