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. 2024 Jul 25;230(1):2-4.
doi: 10.1093/infdis/jiae099.

Escape Velocity-the Launch of Microbiome Therapies

Brendan J Kelly  1 , Jennie H Kwon  2 , Michael H Woodworth  3
Affiliations

Escape Velocity-the Launch of Microbiome Therapies

Brendan J Kelly et al. J Infect Dis. .

Abstract

Food and Drug Administration approval of the first microbiome therapies represents a true expansion the treatment paradigm for Clostridioides difficile but raises new questions about the future role of fecal microbiota transplantation. The authors outline the advances in microbiome therapeutic development that have addressed fecal microbiota transplantation's (FMT's) inherent limitations of safety and scalability. The authors also suggest that as microbiome therapeutic development continues for other indications, FMT will likely remain a necessary model of human microbiota dynamics for translational research.

Keywords: C. difficile; FDA; fecal microbiota transplantation; microbiome; microbiota therapeutics.

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Conflict of interest statement

Potential conflicts of interest. All authors: No reported conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
Maturation of live biotherapeutic product (LBP) clinical development beyond fecal microbiota transplantation (FMT) expands treatment options for patients. Systems biology and microbiome analyses allow for refinement of products beyond FMT that can overcome FMT challenges of safety and scale but may not render FMT obsolete in research settings. As the number of LBPs expand, policy makers should closely monitor the extent to which patients can access therapies with demonstrated safety and efficacy (created with BioRender.com).
See this image and copyright information in PMC

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MeSH terms