Skip to main content

Safety of Bifidobacterium animalis Subsp. Lactis (B. lactis) Strain BB-12-Supplemented Yogurt in Healthy Children

  • 2017-02
  • Journal of Pediatric Gastroenterology and Nutrition 64(2)
    • T. Tan
    • Zhaoyong Ba
    • M. Sanders
    • Frank D'amico
    • R. Roberts
    • K. H. Smith
    • D. Merenstein


Objectives: Probiotics are live microorganisms that may provide health benefits to the individual when consumed in sufficient quantities. For studies conducted on health or disease endpoints on probiotics in the United States, the Food and Administration has required those studies to be conducted as investigational new drugs. This phase I, double-blinded, randomized, controlled safety study represents the first requirement of this pathway. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp. lactis (B lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of children. The secondary aim was to assess the effect of BB-12-supplemented yogurt on the gut microbiota of the children.

Methods: Sixty children ages 1 to 5 years were randomly assigned to consume 4 ounces of either BB-12-supplemented yogurt or nonsupplemented control yogurt daily for 10 days. The primary outcome was to assess safety and tolerability, as determined by the number of reported adverse events.

Results: A total of 186 nonserious adverse events were reported, with no significant differences between the control and BB-12 groups. No significant changes due to probiotic treatment were observed in the gut microbiota of the study cohort.

Conclusions: BB-12-supplemented yogurt is safe and well-tolerated when consumed by healthy children. The present study will form the basis for future randomized clinical trials investigating the potential effects of BB-12-supplemented yogurt in different disease states.

Trial registration: NCT01652287.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium lactis BB-12Change in Gut Microbiota CompositionNeutral
Bifidobacterium lactis BLA80Enhanced Adverse Event ReportingNeutral
⬆ Back to top
Supplement Research and Comparison Website: evidence-based information about supplements, their benefits, potential risks, and their efficacy.
Receive updates about our products, services, sales, and special offers. Unsubscribe anytime. See our Privacy Policy for details on how we handle your information.

Join Our Community

Use to get in touch.