Tolerance and safety evaluation in a large cohort of healthy infants fed an innovative prebiotic formula: a

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Pasqua Piemontese1, Maria L Giannì, Christian P Braegger

  • 1Department of Maternal and Pediatric Sciences, Fondazione IRCCS ''Ca'Granda'' Ospedale Maggiore Policlinico, University of Milan, Milano, Italy.

Plos One
|December 6, 2011
PubMed

Insights

This study found that infant formula with a new oligosaccharide mixture is safe and well-tolerated. It showed similar growth and fewer adverse events compared to standard formula, with softer stools resembling breast milk.

Area of Science:

  • Pediatrics
  • Nutritional Science
  • Gastroenterology

Background:

  • Oligosaccharides in infant formula aim to replicate human milk's benefits.
  • Assessing tolerance and safety of novel oligosaccharide mixtures is crucial for infant nutrition.
  • Human milk oligosaccharides (HMOs) play a vital role in infant gut health and immune development.

Purpose of the Study:

  • To evaluate the tolerance and safety of an infant formula containing a unique oligosaccharide blend.
  • To compare growth parameters, tolerance, and adverse events in infants fed with prebiotic versus control formula.
  • To assess the impact of the novel oligosaccharide mixture on stool consistency and its similarity to breastfed infants.

Main Methods:

  • Multi-center, randomized, double-blind, placebo-controlled trial.
  • Inclusion of healthy term infants (<8 weeks old), both formula-fed and breastfed.
  • Randomization to prebiotic formula (neutral and acidic oligosaccharides) or control formula; assessments at 8, 16, 24, and 52 weeks.

Main Results:

  • Similar growth (weight, length, head circumference) and stool frequency between prebiotic and control formula groups.
  • Prebiotic group showed softer stools, closer to the breastfeeding group, at 8, 16, and 24 weeks.
  • No significant difference in adverse event incidence between the two formula groups.

Conclusions:

  • The infant formula with the innovative oligosaccharide mixture is well-tolerated and safe for healthy infants.
  • The prebiotic formula supports softer stools, indicating potential benefits for gut comfort.
  • Long-term safety demonstrated in a large cohort of infants, supporting its use in infant nutrition.
Abstract

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