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

S Manzano1,2, J De Andrés1, I Castro1

  • 11 Dpto. Nutrición, Bromatología y Tecnología de los Alimentos, Universidad Complutense de Madrid, Av. Puerta de hierro s/n, 28040 Madrid, Spain.

Beneficial Microbes
|May 31, 2017
PubMed

Insights

Probiotic strains Bifidobacterium longum subsp. infantis R0033, Bifidobacterium bifidum R0071, and Lactobacillus helveticus R0052 are safe and well-tolerated in healthy infants aged 3-12 months. The study found no significant differences in growth or adverse events compared to placebo.

Area of Science:

  • Microbiology
  • Pediatrics
  • Gastroenterology

Background:

  • Probiotics, including Bifidobacterium and Lactobacillus species, are widely used for health maintenance.
  • Assessing the safety and tolerance of probiotics in vulnerable populations like infants is crucial.

Purpose of the Study:

  • To evaluate the safety and tolerance of three specific probiotic strains: Bifidobacterium longum subsp. infantis R0033, Bifidobacterium bifidum R0071, and Lactobacillus helveticus R0052.
  • To assess these probiotics in healthy infants aged 3 to 12 months.

Main Methods:

  • A multi-center, randomized, double-blind, placebo-controlled study.
  • 221 healthy full-term infants received daily placebo or one of the three probiotic strains (3×10^9 cfu) for 8 weeks.
  • Safety was assessed through growth monitoring, adverse events (AEs)/serious adverse events (SAEs), urine D-lactic acid, stool characteristics, and medication use.

Main Results:

  • Growth parameters (weight, height, head circumference) showed equivalent changes across all groups.
  • No serious adverse events (SAEs) were reported during the study.
  • The total number of recorded adverse events (AEs) was comparable among the placebo and probiotic groups.

Conclusions:

  • Bifidobacterium longum subsp. infantis R0033, Lactobacillus helveticus R0052, and Bifidobacterium bifidum R0071 are safe for use in infants.
  • These probiotic strains are well-tolerated by healthy infants aged 3 to 12 months.

Keywords:
clinical trialhealthy infantsprobioticssafety and tolerance

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