Clinical research on probiotics: the interface between science and regulation

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
Carmen Tamayo

Abstract

Although there exists some evidence of the safety and efficacy of probiotics for treatment of disease, many of the clinical trials have lacked methodological quality, particularly with regard to protocol design, selection of population, and product characterization. Depending on the regulatory route, data need to be collected carefully to satisfy regulatory requirements in the United States and elsewhere. This article discusses how the regulations for probiotics affect clinical research. It also describes clinical trial design and issues that affect the design of trials for probiotics conducted to improve the scientific evidence for these products.

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Citations

Aug 3, 2011·BMC Medicine·Girish C DeshpandeSanjay K Patole
Aug 5, 2010·Clinical Journal of Oncology Nursing·Karen L Visich, Theresa Pluth Yeo
Sep 1, 2016·Journal of Indian Society of Periodontology·Praveen JayaramVinayak Raghunathan
Mar 13, 2014·Medicine, Health Care, and Philosophy·Vincent BatyGérard Carret

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