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. 2015 Mar 9:9:37-47.
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

Hugo da Costa Ribeiro Júnior  1 , Tereza Cristina Medrado Ribeiro  2 , Angela Peixoto de Mattos  1 , Mariana Pontes  2 , Roseli Oselka Saccardo Sarni  3 , Maria Letícia Santos Cruz  4 , Carlos Alberto Nogueira-de-Almeida  5 , Marisa M Mussi-Pinhata  6 , Rocksane de Carvalho Norton  7 , Philippe Steenhout  8
Affiliations

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

Hugo da Costa Ribeiro Júnior et al. Clin Med Insights Pediatr. .

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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Figures

Figure 1
Figure 1
Flow of infants participating in the study. Abbreviations: ITT, intention-to-treat; PP, per protocol; LTFU, loss to follow-up; SAE, serious adverse event.
Figure 2
Figure 2
Mean volume of formula intake during the exclusive feeding period, intention-to-treat (test formula, n = 65 and control formula, n = 63). Error bars indicate standard deviation. There were no significant differences between groups (analysis of covariance adjusted for birth weight P > 0.1 at all time points).
Figure 3
Figure 3
Mean anthropometric measurements relative to World Health Organization child growth standards, intention-to-treat. (A) Weight-for-age z-scores, (B) length-for-age z-scores, (C) body mass index (BMI)-for-age z-scores, (D) head circumference-for-age z-scores.
Figure 3
Figure 3
Mean anthropometric measurements relative to World Health Organization child growth standards, intention-to-treat. (A) Weight-for-age z-scores, (B) length-for-age z-scores, (C) body mass index (BMI)-for-age z-scores, (D) head circumference-for-age z-scores.
Figure 4
Figure 4
Stool consistency, intention-to-treat. The proportion of days with predominant stool consistencies is shown. Significant differences (Dunnett test, P < 0.05, adjusted by the Hommel method) between the test formula and the other groups are shown by an asterisk (*).
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