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Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula-A Randomized Controlled Trial

Franka Neumer1, Orenci Urraca2, Joaquin Alonso3

  • 1BENEO-Institute, c/o BENEO GmbH, Wormser Str. 11, 67283 Obrigheim, Germany.

Nutrients
|April 30, 2021
PubMed

Insights

Supplementing infant formula with prebiotics like Orafti®Synergy1 positively impacts gut microbiota, increasing beneficial Bifidobacterium levels and reducing infection duration in infants during their first year.

Area of Science:

  • Human Nutrition and Dietetics
  • Pediatrics
  • Microbiology

Background:

  • The infant gut microbiota plays a crucial role in immune system development and overall health.
  • Early life nutrition significantly influences the establishment and composition of the gut microbiome.
  • Prebiotics are recognized for their potential to modulate gut microbiota composition and associated health benefits.

Purpose of the Study:

  • To evaluate the effects of an infant formula supplemented with inulin-type oligosaccharides (Orafti®Synergy1) on infant health outcomes.
  • To assess the impact of prebiotic supplementation on fecal microbiota composition and immunological biomarkers.
  • To determine the safety and tolerance of the prebiotic-supplemented formula during the first year of life.

Main Methods:

  • A prospective, multicenter, randomized, double-blind study involving 160 healthy term infants (<4 months old).
  • Infants received either prebiotic-enriched formula (0.8 g/dL Orafti®Synergy1) or control formula until 12 months.
  • Health outcomes (growth, fever, infections), digestive symptoms, stool consistency, crying/sleeping patterns, and fecal microbiota were monitored.

Main Results:

  • Formulae were well-tolerated; prebiotic group showed significantly lower mean duration of infections (p < 0.05).
  • Higher Bifidobacterium counts and proportions were observed in the prebiotic group at 2 and 6 months (p < 0.05).
  • Softer stools were noted in infants receiving prebiotic formula; a trend towards reduced crying was observed (p=0.0594).

Conclusions:

  • Supplementation with inulin-type prebiotic oligosaccharides beneficially modulates infant gut microbiota, increasing Bifidobacterium levels.
  • Prebiotic supplementation is associated with a reduced duration of infections in infants during the first year of life.
  • The Orafti®Synergy1 supplemented formula demonstrates safety, tolerance, and positive impacts on infant gut health and infection rates.

Keywords:
efficacyinfant formulainfectioninulinoligofructoseprebioticsafety

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