Abstract
Pharmaceutical probiotics have been used as alternative treatments or preventative therapies for a variety of clinical diseases. The overuse of antibiotics and emergence of multiple-antibiotic resistant pathogens has refocused clinical attention on the field of probiotics. Anaerobic infections which seem to respond well to probiotics are infections which involve the disruption of normal microbial flora. Gastrointestinal infections (travelers' diarrhea, antibiotic-associated diarrhea,Clostridium difficiledisease, rotavirus diarrhea) have been studied using the following pharmaceutical probiotics:Saccharomyces boulardii, Lactobacillus caseiGG,Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium bifidum, Streptococcus thermophilusandEnterococcus faecium. Vaginitis has been experimentally studied usingL. acidophilusandL. caseiGG. The efficacy, safety and mechanisms of action of these various probiotics are reviewed. Requirements for drug approval are similar for biologic probiotics and new drug entities and these requirements involve preclinical tolerability studies, pharmacokinetic studies and large, well-controlled blinded clinical trials.
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