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Regulating microbiome manipulation

Nature Medicine volume 25, pages 874–876 (2019)Cite this article

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A crucial consideration for the clinical application of any burgeoning science is when the understanding of that field can be implemented without the risk of unforeseen harm. In our opinion, the need for caution is particularly urgent with respect to increasingly prevalent applications of microbiome science to medicine.

Hardly a week goes by without news of the most recent reported link between an element of the human microbiome and risk of disease. Most of these studies begin as simple correlations of microbes, microbial signatures, or microbial diversity with health outcomes of interest. Increasingly, however, formal clinical trials aimed at modulating and manipulating the human microbiome for better health are being proposed and carried out1,2,3,4,5,6. Prior to the initiation and implementation of therapeutic manipulation of the microbiome, a thoughtful consideration of the need for and role of regulatory challenges ought to be undertaken. These considerations apply to both transfer of naturally occurring microbial communities and cultured microbial consortia.

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Authors and Affiliations

  1. Departments of Obstetrics & Gynecology, Molecular & Human Genetics, and Cell & Molecular Biology, Baylor College of Medicine and Texas Children’s Hospital, Houston, TX, USA

    Kjersti Aagaard

  2. Department of Medicine, Division of Infectious Diseases, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

    Elizabeth Hohmann

Authors
  1. Kjersti Aagaard
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  2. Elizabeth Hohmann
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Correspondence to Kjersti Aagaard.

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The authors declare no competing interests.

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Aagaard, K., Hohmann, E. Regulating microbiome manipulation. Nat Med 25, 874–876 (2019). https://doi.org/10.1038/s41591-019-0451-1

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