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March 3, 2020

The Probiotic Conundrum: Regulatory Confusion, Conflicting Studies, and Safety Concerns

Author Affiliations
  • 1Alberta Children’s Hospital, Calgary, Alberta, Canada
  • 2Alberta Children’s Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
  • 3Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio
  • 4University of Cincinnati College of Medicine, Cincinnati, Ohio
  • 5St Louis Children’s Hospital, St Louis, Missouri
  • 6Washington University in St Louis School of Medicine, St Louis, Missouri
JAMA. 2020;323(9):823-824. doi:10.1001/jama.2019.22268

It is increasingly clear that microbial communities have important functions in immunologic development, infection prevention, and intestinal barrier maintenance. These roles lend credence to the notion that probiotic (ie, live organisms that putatively benefit their host) administration can alter the human gut microbiome. Given that numerous meta-analyses and review articles and marketing are supportive of probiotics, it is easy to understand why medical professionals adopt “can’t hurt, might help” attitudes toward these substances. However, the paucity of high-quality data supporting the value of probiotics, concerns about potentially biased reviews of their efficacy, the complex framework in which probiotics are regulated and sold, and the limited but increasingly concerning safety information suggest that this approach may not be appropriate.

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