Current Progress in the Development of Next-Generation Probiotics: Background, Definition and Regulation

次世代益生菌當前的發展 : 背景、定義與法規

傳統益生菌的概念最初起源於1907 年 Elie Metchnikoff 的敘述，在年長的保加利亞長者中，經常攝入含有乳酸菌 (LAB) 的發酵乳製品如酸奶，與增強健康和長壽有關，此對於食用傳統益生菌進而促進健康的概念普遍被廣泛接受。近年來，由於迅速發展的人類腸道菌相研究中所獲得的知識，特別的新型細菌菌株會被開發為次世代益生菌 (NGP)，目的是維持腸道生態系統的穩定，並預防慢性炎症相關疾病的發展。除了作為食品補充劑或醫療用食品外，一些 NGP 之後可能進一步被開發為活菌藥物，即活的生物治療產品(LBP)，及生物藥。 此外，促進 NGP 生長之物質 (益生元)、無活性細菌產品 (副益生菌)以及細菌所衍生之化合物 (後生元)的潛在用途，目前也正深入研究中。在這篇綜述中，我們首先對傳統益生菌、NGPs及其相關發展進行簡要介紹。 然後，我們也關注當前的相關法規，尤其是美國食品和藥物管理局 (FDA) 對LBP 開發 NGP 的法規。不久的未來， NGP 可開發為新的預防性，甚至治療性製劑來改善疾病。

The concept of traditional probiotics initially originated from the observations of Elie Metchnikoff in 1907. The widely accepted belief was that consumption of fermented dairy products such as yogurt, containing lactic acid bacteria (LAB), enhanced the health and longevity of Bulgarian elders. Recent studies on the human gut microbiota have revealed specific and novel bacterial strains that function as next-generation probiotics (NGPs) to maintain the homeostasis of the intestinal ecosystem and ameliorate systemic chronic inflammation-related diseases. In addition to being developed as food supplements or medical foods, some NGPs may also be developed as live bacterial drugs, Live Bio-Therapeutic Products (LBPs), or pharmabiotics. Furthermore, the potential use of NGP growth- promoting substrates (prebiotics), non-viable bacteria (paraprobiotics), as well as bacterially-derived compounds (postbiotics) also are currently under intensive study. The development of NGPs as new preventive or even therapeutics for disease amelioration is expected. This review provides a brief introduction to traditional probiotics, followed by NGPs and their related developments. We then focused on the current regulations, particularly those from the Food and Drug Administration (FDA) of the USA regarding the development of NGP towards LBP.