Safety and tolerance of a probiotic formula in early infancy comparing two probiotic agents: a pilot study

Zvi Weizman1, Ahmed Alsheikh

  • 1Pediatric Gastroenterology and Nutrition Unit, Soroka Medical Center, P.O. Box 151, Beer-Sheva 84101, Israel. wzvi@bgumail.bgu.ac.il

Insights

Two probiotic formulas containing Bifidobacterium lactis or Lactobacillus reuteri were found safe and well-tolerated in infants. These probiotic supplements did not negatively impact infant growth, feeding, or behavior.

Area of Science:

  • Pediatric Nutrition
  • Gastroenterology
  • Microbiology

Background:

  • Infant formula selection is crucial for growth and development.
  • Probiotics are increasingly studied for their potential health benefits in infants.
  • Safety and tolerance are primary concerns when introducing new formula ingredients.

Purpose of the Study:

  • To evaluate the safety and tolerance of infant formulas supplemented with specific probiotic strains.
  • To compare the effects of Bifidobacterium lactis (BB-12) and Lactobacillus reuteri (ATCC 55730) supplemented formulas against a placebo formula.

Main Methods:

  • A prospective, randomized, placebo-controlled trial was conducted.
  • Healthy, full-term infants under 4 months received one of three formulas for 4 weeks.
  • Outcomes included growth parameters, feeding, stooling, behavior, and adverse events.

Main Results:

  • Fifty-nine infants participated, with no significant baseline differences between groups.
  • Both supplemented formulas were well-accepted and showed no adverse effects.
  • No significant differences were observed in growth, feeding, stooling, or behavior between the probiotic and placebo groups.

Conclusions:

  • Formulas supplemented with Lactobacillus reuteri or Bifidobacterium lactis are safe and well-tolerated in early infancy.
  • These probiotic supplements do not adversely affect infant growth, stooling habits, or behavior.
  • The findings support the use of these specific probiotic strains in infant formulas.
Abstract

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