Research Group of Industrial Microbiology and Food Biotechnology (IMDO), Department of Bioengineering Sciences (DBIT), Vrije Universiteit Brussel, Pleinlaan 2, 1050, Brussels, Belgium.
Yakult Europe BV, Schutsluisweg 1, 1332 EN, Almere, The Netherlands.
Eur J Med Res. 2021 May 4;26(1):40. doi: 10.1186/s40001-021-00509-7.
Traditional probiotics are increasingly being used in a medical context. The use of these products as drugs is considerably different from the traditional use as food or food supplements, as, obviously, the target population is different (diseased versus healthy or at risk population). Besides the target population, also the regulatory context is different, mainly with respect to production, administration regime and type of clinical studies required. In this paper we will, besides the regulatory differences, focus on aspects that may impact the efficacy of a live biotherapeutic product (drug), especially in a clinical setting. The impact of the dosage seems to depend on the strain and the application and may follow some rationale. In contrast, information on the impact of the time of administration or diet, is often still lacking. The matrix and the use of protective measures may clearly have an impact on the survival and efficacy of the strain.
传统益生菌越来越多地被应用于医学领域。这些产品作为药物的使用与作为食品或食品补充剂的传统用途有很大的不同，因为显然目标人群是不同的（患病人群与健康人群或高危人群）。除了目标人群，监管环境也不同，主要是在生产、管理方案和所需临床研究类型方面。在本文中，除了监管方面的差异，我们还将重点关注可能影响活菌治疗产品（药物）疗效的方面，特别是在临床环境中。剂量的影响似乎取决于菌株和应用，并且可能遵循一定的原理。相比之下，关于给药时间或饮食的影响的信息通常仍然缺乏。基质和保护措施的使用显然会对菌株的生存和疗效产生影响。
