The colonization by the probiotic Lactobacillus casei subsp. rhamnosus Lcr35 of the gastrointestinal tracts of mice and humans was studied. The mice were orally given 10 9 CFU of Lcr35 either once or three times at 24-h intervals. A 16S ribosomal nucleic probe used in hybridization assays detected Lcr35 in the feces of mice for up to 3 days after the feeding, at a level of 10 8 to 10 9 CFU/g of feces. In the human assay, 12 healthy volunteers were enrolled in a randomized trial and ingested Lcr35 at a dosage of 10 8 or 10 10 or 10 12 CFU every day for 7 days. Then, after a 3-week posttreatment period, there was a second intake period similar to the first one. Analysis of fecal samples showed significant increases in the number of lactobacilli during the first intake period, whatever the dose given. The greatest increases were observed in subjects harboring the lowest indigenous population of Lcr35-like bacteria. During the 3-week posttreatment period, the number of CFU slightly decreased over time, and an increase, although not a statistically significant one, was observed during the second test period. These findings suggest that Lcr35 is able to survive within the gastrointestinal tract.Probiotics have been defined as viable microorganisms that have a beneficial effect on health (3). Oral consumption of probiotics has been associated with the prevention or cure of diverse intestinal disorders such as antibiotic-induced diarrheal disease, viral and bacterial diarrhea, lactose intolerance, and inflammatory bowel diseases (10). Much of the early evidence on the actual health effects of probiotics was anecdotal, but in recent years there has been accumulating evidence from rigorous clinical studies that certain well-characterized strains have real health-promoting properties (7). Many mechanisms by which probiotics may protect the host from intestinal disorders have been proposed, including production of inhibitory substances, blockage of adhesion sites, competition for nutrients, and stimulation of immunity. Whatever the underlying mechanism, in order to produce their health effects, the probiotic microorganisms must be able to survive within the gastrointestinal (GI) tract (5) and persist at high levels in the intestine. The minimum effective dose is not precisely known, but the usual recommended oral administration is in excess of 10 9 CFU/day. Several in vitro assays have been used to demonstrate the survival of probiotic strains inside the GI tract, including bile and acid resistance assays (1). However, only human trials can provide evidence of the survival of the probiotic strains in vivo and therefore are required as a basis of a credible claim.Lactobacillus casei subsp. rhamnosus Lcr35 has been successfully exploited commercially as a pharmaceutical product for more than 20 years. Its beneficial effects include treatment and prevention of nonorganic diarrhea. We recently showed in vitro that this strain has probiotic activities such as the ability to adhere to intestinal cells and antibacterial activity a...