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Clinical Trial
. 2017 Feb;64(2):302-309.
doi: 10.1097/MPG.0000000000001272.

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

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Free PMC article
Clinical Trial

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

Tina P Tan et al. J Pediatr Gastroenterol Nutr. .
Free PMC article

Abstract

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: ClinicalTrials.gov NCT01652287.

Conflict of interest statement

Conflicts of InterestD.J.M. previously served as a paid expert witness for General Mills, Inc., Nestlé Nutrition, Bayer and the Proctor & Gamble Company. M.E.S. consults for numerous probiotic manufacturers. The remaining authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Linear discriminant analysis (LDA) scores computed for features differentially abundant between control yogurt and BB-12® yogurt drink. (a) Operational taxonomic unit (OTU) comparison at day 0 (prior to interventions) (b) OTU comparison at day 10 (after interventions)
Figure 1
Figure 1
Linear discriminant analysis (LDA) scores computed for features differentially abundant between control yogurt and BB-12® yogurt drink. (a) Operational taxonomic unit (OTU) comparison at day 0 (prior to interventions) (b) OTU comparison at day 10 (after interventions)
Figure 2
Figure 2
Alpha rarefaction plots grouped by subject (Each rarefaction plot represents species richness or alpha-diversity of one subject or one group within the sample metadata. It is a curve of the number of species as a function of the number of samples or simulated sequencing effort.)
Figure 3
Figure 3
Alpha rarefaction plots grouped by total number of housemates
Figure 4
Figure 4
Alpha rarefaction plots grouped by age of participant (in years)
Figure 5
Figure 5
Alpha rarefaction plots grouped by adverse event severity grade NA: not applicable/no AE reported; 1: mild; 2: moderate; 4: potential life threatening

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