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Safety and tolerance of three probiotic strains in healthy infants: a multi-centre randomized, double-blind, placebo-controlled trial.

Study Design

Type
Randomized Controlled Trial (RCT)
Population
221 healthy full-term infants aged 3 to 12 months
Methods
multi-centre randomized, double-blind, placebo-controlled intervention study, daily placebo or one of 3 probiotic strains (3×10^9 cfu) for 8 weeks
Blinding
Double-blind
Duration
8 week intervention period
  • Rigorous Journal
Some strains of species belonging to the genera Bifidobacterium and Lactobacillus are used in order to maintain health. Although these organisms have a long record of safe use, it is important to assess their safety and tolerance in potentially vulnerable populations, such as infants. The objective of this study was to evaluate the safety and tolerance of three probiotic strains (Bifidobacterium longum subsp. infantis R0033, Bifidobacterium bifidum R0071 and Lactobacillus helveticus R0052) in healthy infants aged 3 to 12 months. A multi-centre randomized, double-blind, placebo-controlled intervention study with 221 healthy full-term infants was conducted. Infants received either a placebo or one of the 3 probiotic strains (3×109 cfu) daily during an 8 week intervention period. Growth (weight, height and head circumference), adverse events (AEs)/serious adverse events (SAEs), concentrations of D-lactic acid in urine samples, characteristics of the stools and use of medication were collected for safety evaluation. All 4 groups were homogeneous with respect to age, gender, feeding type, ethnicity, height, weight and head circumference at the start of the study. The results showed that changes in growth (weight, height and head circumference) were equivalent in all 4 groups. No SAEs were reported. Total number of AEs recorded was equivalent in all groups. Thus, the use of B. infantis R0033, L. helveticus R0052 and B. bifidum R0071 in infancy is safe, and well tolerated.

Research Insights

Adverse Events Reported

  • Lactobacillus helveticus R0052→adverse events

    Total number of AEs recorded was equivalent in all groups.

    Finding
    No significant difference
    Significant
    No
  • Lactobacillus helveticus R0052→growth measures

    The results showed that changes in growth (weight, height and head circumference) were equivalent in all 4 groups.

    Finding
    No significant difference
    Significant
    No
  • Lactobacillus helveticus R0052→Overall tolerability

    Thus, the use of B. infantis R0033, L. helveticus R0052 and B. bifidum R0071 in infancy is safe, and well tolerated.

    Finding
    Reported
  • Lactobacillus helveticus R0052→serious adverse event

    No SAEs were reported.

    Finding
    Reported
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