![]() Several recent reviews have summarized results from clinical studies evaluating the efficacy of probiotics in diarrheal illness ( 4– 12). Recent increases in the incidence and severity of Clostridium difficile infection (CDI) have led some clinicians to consider use of probiotics as “drugs,” either alone or in combination with traditional antimicrobial agents for the prevention and treatment of CDI. ![]() In the United States, probiotic products are marketed to a generally healthy population as foods or dietary supplements ( 3). The term probiotic can be subcategorized to include probiotic drugs, probiotic foods (e.g., foods, food ingredients, and dietary supplements), direct-fed microbials (probiotics for animal use), and designer probiotics (genetically modified probiotics) ( 2). Probiotics are defined by the Food and Agriculture Organization of the World Health Organization as live microorganisms that, when administered in adequate amounts, confer a health benefit on the host ( 1). To ensure patient safety, probiotics should be properly handled during administration. Before use of a probiotic is considered for hospitalized patients, careful assessment of risk versus benefit must be made. Saccharomyces fungemia secondary to use of the probiotic has been described for patients who are critically ill, are receiving nutrition enterally, or have a central venous catheter. However, since recent increases in incidence and severity of Clostridium difficile infection, probiotics have been used to treat recurrent and/or refractory disease in hospitalized patients. Saccharomyces boulardii is a probiotic regulated as a dietary supplement intended for use by the general healthy population, not as a drug to prevent, treat, or mitigate disease. ![]() For dietary supplements, premarketing demonstration of safety and efficacy and approval by the Food and Drug Administration are not required only premarket notification is required. ![]() dietary supplement), regulatory requirements differ greatly. Depending on intended use of a probiotic (drug vs. ![]()
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