Journal Article

Clinical Research on Probiotics: The Interface between Science and Regulation

Carmen Tamayo

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 46, issue Supplement_2, pages S101-S103
Published in print February 2008 | ISSN: 1058-4838
Published online February 2008 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/523332
Clinical Research on Probiotics: The Interface between Science and Regulation

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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.

Journal Article.  2452 words. 

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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