Preclinical Testing in the Development of Probiotics: A Regulatory Perspective withBacillusStrains as an Example
Open Access
- 1 February 2008
- journal article
- Published by Oxford University Press (OUP) in Clinical Infectious Diseases
- Vol. 46 (s2), S92-S95
- https://doi.org/10.1086/523334
Abstract
Preclinical testing of the microbial strains is the first important step in the development of probiotics. Requirements for the set of tests can vary depending on the bacterial species and the expected mechanism of action in the organism. Common approaches to preclinical testing of probiotic strains include strain identification (i.e., determination of phenotypic and genotypic properties), safety evaluation (i.e., characterization of history of use [safety contact], assessment of resistance to antibiotics, and evaluation of pathogenic properties in vitro and in animal models), and efficacy testing (i.e., functional characterization). Future progress in probiotics requires more studies to determine the mechanisms of their action, as well as an understanding of the basis and mechanisms of pathogenicity for different probiotic strains. Special attention should be given to recombinant probiotics, particularly in the formulation of criteria for selection of the host strain, for assessment of environmental safety, and for tracing the fate of recombinant DNA in vitro and in vivo.This publication has 27 references indexed in Scilit:
- High-Level Vancomycin-Resistant Staphylococcus aureus Isolates Associated with a Polymicrobial BiofilmAntimicrobial Agents and Chemotherapy, 2007
- Isolation and characterization of verocytotoxin-producing Escherichia coli O157 from Turkish cattleInternational Journal of Food Microbiology, 2006
- Antimicrobial susceptibility of bifidobacteriaJournal of Antimicrobial Chemotherapy, 2005
- The Importance of Guidelines in the Development and Application of ProbioticsCurrent Pharmaceutical Design, 2005
- Glycopeptide-resistance transferability from vancomycin-resistant enterococci of human and animal source to Listeria spp.Letters in Applied Microbiology, 2004
- Probiotics: Isolated bacteria strain or mixtures of different strains?Drugs of Today, 2003
- Probiotic Enterococcus faecium Strain Is a Possible Recipient of the vanA Gene ClusterClinical Infectious Diseases, 2001
- Probiotics and safetyThe American Journal of Clinical Nutrition, 2001
- Detection of toxigenic strains ofBacillus cereusand otherBacillusspp. with an improved cytotoxicity assayLetters in Applied Microbiology, 1999
- Antibiotic Susceptibility as a Taxonomic Characteristic of the Genus BacillusInternational Journal of Systematic and Evolutionary Microbiology, 1995