Cargando…

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

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 immun...

Descripción completa

Detalles Bibliográficos
Autores principales: da Costa Ribeiro, Hugo, Ribeiro, Tereza Cristina Medrado, de Mattos, Angela Peixoto, Pontes, Mariana, Sarni, Roseli Oselka Saccardo, Cruz, Maria Letícia Santos, Nogueira-de-Almeida, Carlos Alberto, Mussi-Pinhata, Marisa M, de Carvalho Norton, Rocksane, Steenhout, Philippe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Libertas Academica 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4357629/
https://www.ncbi.nlm.nih.gov/pubmed/25788839
http://dx.doi.org/10.4137/CMPed.S17841
_version_ 1782361168118022144
author da Costa Ribeiro, Hugo
Ribeiro, Tereza Cristina Medrado
de Mattos, Angela Peixoto
Pontes, Mariana
Sarni, Roseli Oselka Saccardo
Cruz, Maria Letícia Santos
Nogueira-de-Almeida, Carlos Alberto
Mussi-Pinhata, Marisa M
de Carvalho Norton, Rocksane
Steenhout, Philippe
author_facet da Costa Ribeiro, Hugo
Ribeiro, Tereza Cristina Medrado
de Mattos, Angela Peixoto
Pontes, Mariana
Sarni, Roseli Oselka Saccardo
Cruz, Maria Letícia Santos
Nogueira-de-Almeida, Carlos Alberto
Mussi-Pinhata, Marisa M
de Carvalho Norton, Rocksane
Steenhout, Philippe
author_sort da Costa Ribeiro, Hugo
collection PubMed
description 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.
format Online
Article
Text
id pubmed-4357629
institution National Center for Biotechnology Information
language English
publishDate 2015
publisher Libertas Academica
record_format MEDLINE/PubMed
spelling pubmed-43576292015-03-18 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 da Costa Ribeiro, Hugo Ribeiro, Tereza Cristina Medrado de Mattos, Angela Peixoto Pontes, Mariana Sarni, Roseli Oselka Saccardo Cruz, Maria Letícia Santos Nogueira-de-Almeida, Carlos Alberto Mussi-Pinhata, Marisa M de Carvalho Norton, Rocksane Steenhout, Philippe Clin Med Insights Pediatr Original Research 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. Libertas Academica 2015-03-09 /pmc/articles/PMC4357629/ /pubmed/25788839 http://dx.doi.org/10.4137/CMPed.S17841 Text en © 2015 the author(s), publisher and licensee Libertas Academica Ltd. This is an open-access article distributed under the terms of the Creative Commons CC-BY-NC 3.0 License.
spellingShingle Original Research
da Costa Ribeiro, Hugo
Ribeiro, Tereza Cristina Medrado
de Mattos, Angela Peixoto
Pontes, Mariana
Sarni, Roseli Oselka Saccardo
Cruz, Maria Letícia Santos
Nogueira-de-Almeida, Carlos Alberto
Mussi-Pinhata, Marisa M
de Carvalho Norton, Rocksane
Steenhout, Philippe
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4357629/
https://www.ncbi.nlm.nih.gov/pubmed/25788839
http://dx.doi.org/10.4137/CMPed.S17841
work_keys_str_mv AT dacostaribeirohugo normalgrowthofhealthyinfantsbornfromhivmothersfedareducedproteininfantformulacontainingtheprebioticsgalactooligosaccharidesandfructooligosaccharidesarandomizedcontrolledtrial
AT ribeiroterezacristinamedrado normalgrowthofhealthyinfantsbornfromhivmothersfedareducedproteininfantformulacontainingtheprebioticsgalactooligosaccharidesandfructooligosaccharidesarandomizedcontrolledtrial
AT demattosangelapeixoto normalgrowthofhealthyinfantsbornfromhivmothersfedareducedproteininfantformulacontainingtheprebioticsgalactooligosaccharidesandfructooligosaccharidesarandomizedcontrolledtrial
AT pontesmariana normalgrowthofhealthyinfantsbornfromhivmothersfedareducedproteininfantformulacontainingtheprebioticsgalactooligosaccharidesandfructooligosaccharidesarandomizedcontrolledtrial
AT sarniroselioselkasaccardo normalgrowthofhealthyinfantsbornfromhivmothersfedareducedproteininfantformulacontainingtheprebioticsgalactooligosaccharidesandfructooligosaccharidesarandomizedcontrolledtrial
AT cruzmarialeticiasantos normalgrowthofhealthyinfantsbornfromhivmothersfedareducedproteininfantformulacontainingtheprebioticsgalactooligosaccharidesandfructooligosaccharidesarandomizedcontrolledtrial
AT nogueiradealmeidacarlosalberto normalgrowthofhealthyinfantsbornfromhivmothersfedareducedproteininfantformulacontainingtheprebioticsgalactooligosaccharidesandfructooligosaccharidesarandomizedcontrolledtrial
AT mussipinhatamarisam normalgrowthofhealthyinfantsbornfromhivmothersfedareducedproteininfantformulacontainingtheprebioticsgalactooligosaccharidesandfructooligosaccharidesarandomizedcontrolledtrial
AT decarvalhonortonrocksane normalgrowthofhealthyinfantsbornfromhivmothersfedareducedproteininfantformulacontainingtheprebioticsgalactooligosaccharidesandfructooligosaccharidesarandomizedcontrolledtrial
AT steenhoutphilippe normalgrowthofhealthyinfantsbornfromhivmothersfedareducedproteininfantformulacontainingtheprebioticsgalactooligosaccharidesandfructooligosaccharidesarandomizedcontrolledtrial