Risk and safety of probiotics

Clin Infect Dis. 2015 May 15;60 Suppl 2(Suppl 2):S129-34. doi: 10.1093/cid/civ085.


Probiotics have been used safely for years. Safety outcomes are inconsistently reported in published clinical trials. In 2011, a report released by the Agency for Healthcare Research and Quality concluded that, although the existing probiotic clinical trials reveal no evidence of increased risk, "the current literature is not well equipped to answer questions on the safety of probiotics in intervention studies with confidence." Critics point out that the preponderance of evidence, including the long history of safe probiotic use as well as data from clinical trials, and animal and in vitro studies all support the assumption that probiotics are generally safe for most populations. Theoretical risks have been described in case reports, clinical trial results and experimental models, include systemic infections, deleterious metabolic activities, excessive immune stimulation in susceptible individuals, gene transfer and gastrointestinal side effects. More research is needed to properly describe the incidence and severity of adverse events related to probiotics.

Keywords: Lactobacillus; Saccharomyces; bacteremia; probiotics; safety.

Publication types

  • Research Support, N.I.H., Extramural
  • Review

MeSH terms

  • Clinical Trials as Topic
  • Fungemia / etiology
  • Gastrointestinal Tract / physiology
  • Gene Transfer, Horizontal
  • Humans
  • Lactobacillus / pathogenicity
  • Probiotics / adverse effects*
  • Probiotics / standards
  • Risk
  • Saccharomyces / pathogenicity
  • Sepsis / etiology
  • United States