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

  • 2004-02
  • The American Journal of Clinical Nutrition 79(2)
    • J. Saavedra
    • A. Abi-hanna
    • N. Moore
    • R. Yolken

Abstract

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.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Streptococcus thermophilus SD-5207Achieved Adequate Infant GrowthNeutral
Moderate
Streptococcus thermophilus SD-5207Reduced Antibiotic UsageBeneficial
Large
Streptococcus thermophilus SD-5207Reduced Colic or IrritabilityBeneficial
Large
Streptococcus thermophilus SEBioticAchieved Adequate Infant GrowthNeutral
Moderate
Streptococcus thermophilus SEBioticImproved Safe Consumption PracticesNeutral
Small
Streptococcus thermophilus SEBioticReduced Antibiotic UsageBeneficial
Large
Streptococcus thermophilus SEBioticReduced Colic or IrritabilityBeneficial
Large
Streptococcus thermophilus SL-21Achieved Adequate Infant GrowthNeutral
Moderate
Streptococcus thermophilus SL-21Reduced Antibiotic UsageBeneficial
Large
Streptococcus thermophilus SL-21Reduced Colic or IrritabilityBeneficial
Large
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