Validating bifidobacterial species and subspecies identity in commercial probiotic products

Pediatr Res. 2016 Mar;79(3):445-52. doi: 10.1038/pr.2015.244. Epub 2015 Nov 16.


Background: The ingestion of probiotics to attempt to improve health is increasingly common; however, quality control of some commercial products can be limited. Clinical practice is shifting toward the routine use of probiotics to aid in prevention of necrotizing enterocolitis in premature infants, and probiotic administration to term infants is increasingly common to treat colic and/or prevent atopic disease. Since bifidobacteria dominate the feces of healthy breast-fed infants, they are often included in infant-targeted probiotics.

Methods: We evaluated 16 probiotic products to determine how well their label claims describe the species of detectable bifidobacteria in the product. Recently developed DNA-based methods were used as a primary means of identification, and were confirmed using culture-based techniques.

Results: We found that the contents of many bifidobacterial probiotic products differ from the ingredient list, sometimes at a subspecies level. Only 1 of the 16 probiotics perfectly matched its bifidobacterial label claims in all samples tested, and both pill-to-pill and lot-to-lot variation were observed.

Conclusion: Given the known differences between various bifidobacterial species and subspecies in metabolic capacity and colonization abilities, the prevalence of misidentified bifidobacteria in these products is cause for concern for those involved in clinical trials and consumers of probiotic products.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Bacterial Typing Techniques*
  • Bifidobacterium / classification
  • Bifidobacterium / genetics*
  • DNA, Bacterial / analysis
  • Enterocolitis, Necrotizing / prevention & control*
  • Feces / microbiology
  • Genome, Bacterial
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Polymorphism, Restriction Fragment Length
  • Probiotics / therapeutic use*
  • Sequence Analysis, DNA
  • Species Specificity
  • Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization


  • DNA, Bacterial