Hibberd Patricia L, Davidson Lisa
Department of Geographic Medicine and Infectious Diseases, Tufts New England Medical Center, and 2Tufts University School of Medicine, Boston, Massachusetts 02111, USA.
Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S137-40; discussion S144-51. doi: 10.1086/523321.
Probiotics have been in widespread use since ancient times and are increasingly being consumed to maintain health and to prevent and treat a wide range of conditions. In the United States, probiotics are considered to be foods or biologics, depending on their intended use. This article addresses the similarities and differences between approaches to conducting clinical trials of probiotics as foods (which leads to health claims) or as biologics (which leads to therapeutic claims). Most probiotics are manufactured as foods, which makes it challenging for academic investigators in the United States to meet the requirements of an Investigational New Drug application that enables them to study the therapeutic effects of these novel agents. Although it is important to ensure the safety and quality of probiotic products, there also may be value in adapting the US Food and Drug Administration's Guidance for Industry for Botanical Products to probiotic products, in part to allow the research agenda to move forward with products for which there are no safety concerns.
益生菌自古以来就被广泛使用，人们越来越多地食用它们来维持健康以及预防和治疗各种疾病。在美国，根据其预期用途，益生菌被视为食品或生物制品。本文探讨了将益生菌作为食品（可产生健康声明）或生物制品（可产生治疗声明）进行临床试验的方法之间的异同。大多数益生菌作为食品生产，这使得美国的学术研究人员难以满足研究性新药申请的要求，从而无法研究这些新型制剂的治疗效果。虽然确保益生菌产品的安全性和质量很重要，但部分地调整美国食品药品监督管理局针对植物性产品的行业指南以适用于益生菌产品可能也有价值，这样做部分是为了让那些不存在安全问题的产品的研究议程能够推进。
