Next-generation probiotics: the spectrum from probiotics to live biotherapeutics

Abstract

The leading probiotics currently available to consumers are generally drawn from a narrow range of organisms. Knowledge of the gut microbiota and its constituent actors is changing this paradigm, particularly given the phylogenetic range and relatively unknown characteristics of the organisms under investigation as novel therapeutics. For this reason, and because their development is likely to be more amenable to a pharmaceutical than a food delivery route, these organisms are often operationally referred to as next-generation probiotics, a concept that overlaps with the emerging concept of live biotherapeutic products. The latter is a class of organisms developed exclusively for pharmaceutical application. In this Perspective, we discuss what lessons have been learned from working with traditional probiotics, explore the kinds of organisms that are likely to be used as novel microbial therapeutics, discuss the regulatory framework required, and propose how scientists may meet this challenge.

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Figure 1: Timeline of selected milestones in the history of probiotics and next-generation probiotics.
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Acknowledgements

We thank the panel members of the ISAPP 2016 meeting for stimulating discussions, and M. E. Sanders for reviewing the section on regulations. The opinions in this article are those of the authors only, and do not represent a consensus of the ISAPP convened panel.

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P.W.O.T. and C.H. are funded in part by Science Foundation Ireland (APC/SFI/12/RC/2273) in the form of a research centre which is/has recently been in receipt of research grants from the following companies: Cremo, Mead Johnson Nutrition, Kerry, General Mills, GE Healthcare, Friesland Campina, Sigmoid, Alimentary Health, Second Genome, Nutricia, Danone, Janssen, AbbVie, Suntory Morinaga Milk Industry Ltd, Pfizer Consumer Health, Radisens, 4D Pharma, Crucell, Adare Pharma, Artugen Therapeutics, Caelus. P.W.O.T. is a founder shareholder of Tucana Health Ltd. C.H. is a founder shareholder in Artugen therapeutics. These relationships with industry have no bearing on the present work and neither influenced nor constrained it. J.R.M. has consulted and received payment from Cultech Ltd, Takeda Pharmaceuticals and Unilever.

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Correspondence to Paul W. O’Toole.

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O’Toole, P., Marchesi, J. & Hill, C. Next-generation probiotics: the spectrum from probiotics to live biotherapeutics. Nat Microbiol 2, 17057 (2017). https://doi.org/10.1038/nmicrobiol.2017.57

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