Long-term consumption of infant formulas containing live probiotic bacteria: tolerance and safety

Am J Clin Nutr. 2004 Feb;79(2):261-7. doi: 10.1093/ajcn/79.2.261.


Background: Nonpathogenic live bacteria are consumed as food by many children, particularly in the form of yogurt. The tolerance and safety of long-term consumption of specific types and strains of probiotic bacteria are not well documented.

Objective: The goal was to evaluate tolerance to formulas containing 2 levels of probiotic supplementation and effects on growth, general clinical status, and intestinal health in free-living healthy infants.

Design: This was a prospective, double-blind, randomized, placebo-controlled study of healthy infants aged 3-24 mo. Infants were assigned to receive a standard milk-based formula containing 1 x 10(7) colony-forming units (CFU)/g each of Bifidobacterium lactis and Streptococcus thermophilus, formula containing 1 x 10(6) CFU/g each of B. lactis and S. thermophilus, or unsupplemented formula. Clinical outcomes included formula intake, gastrointestinal tolerance, anthropometric measures, daycare attendance, and history of illness.

Results: One hundred eighteen infants aged ( +/- SD) 7.0 +/- 2.9 mo at enrollment consumed formula for 210 +/- 127 d. There were no significant differences in age, sex, formula consumption, or length of study between groups. The supplemented formulas were well accepted and were associated with a lower frequency of reported colic or irritability (P < 0.001) and a lower frequency of antibiotic use (P < 0.001) than was the unsupplemented formula. There were no significant differences between groups in growth, health care attention seeking, daycare absenteeism, or other health variables.

Conclusion: Long-term consumption of formulas supplemented with B. lactis and S. thermophilus was well tolerated and safe and resulted in adequate growth, reduced reporting of colic or irritability, and a lower frequency of antibiotic use.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bifidobacterium
  • Child, Preschool
  • Double-Blind Method
  • Drug Tolerance
  • Female
  • Growth*
  • Humans
  • Infant
  • Infant Food*
  • Intestines / drug effects
  • Male
  • Probiotics / administration & dosage
  • Probiotics / pharmacology*