School of Microbiology &APC Microbiome Institute, University College Cork, Cork T12 YN60, Ireland.
School of Biosciences, Cardiff University, Cardiff CF10 3AT, UK.
Nat Microbiol. 2017 Apr 25;2:17057. doi: 10.1038/nmicrobiol.2017.57.
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.
目前可供消费者选择的主要益生菌通常来自于有限的几种微生物。人们对肠道微生物群及其组成部分的了解正在改变这种模式，特别是由于研究中的新型治疗药物所涉及的微生物在进化上的范围很广，而且其特征相对未知。出于这个原因，并且由于它们的开发可能更适合制药而不是食品输送途径，这些微生物通常在操作上被称为下一代益生菌，这一概念与新兴的活体生物治疗产品的概念重叠。后者是专门为药物应用开发的一类微生物。在本观点中，我们讨论了从使用传统益生菌中获得的经验教训，探讨了可能用作新型微生物治疗药物的微生物种类，讨论了所需的监管框架，并提出了科学家如何应对这一挑战。
