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 pathoge
ns has refocused clinical attention on the field of probiotics. Anaero
bic infections which seem to respond well to probiotics are infections
which involve the disruption of normal microbial flora. Gastrointesti
nal infections (travelers' diarrhea, antibiotic-associated diarrhea, C
lostridium difficile disease, rota-virus diarrhea) have been studied u
sing the following pharmaceutical probiotics: Saccharomyces boulardii,
Lactobacillus casei GG, Lactobacillus acidophilus, Lactobacillus bulg
aricus, Bifidobacterium bifidum, Streptococcus thermophilus and Entero
coccus faecium. Vaginitis has been experimentally studied using L. aci
dophilus and L. casei GG. The efficacy, safety and mechanisms of actio
n of these various probiotics are reviewed. Requirements for drug appr
oval are similar for biologic probiotics and new drug entities and the
se requirements involve preclinical tolerability studies, pharmacokine
tic studies and large, well-controlled blinded clinical trials. (C) 19
97 Academic Press.