c Vancomycin-resistant enterococci (VRE) are endemic in health care settings. These organisms colonize the gastrointestinal tract and can lead to infection which is associated with increased mortality. There is no treatment for VRE colonization. We conducted a randomized, double-blind, placebo-controlled clinical trial to examine the safety and efficacy of administration of the probiotic Lactobacillus rhamnosus GG (LGG) for the reduction or elimination of intestinal colonization by VRE. Colonized adults were randomized to receive LGG or placebo for 14 days. Quantitative stool cultures for LGG and VRE were collected at baseline and days 7, 14, 21, 28, and 56. Day 14 stool samples from some subjects were analyzed by quantitative PCR (qPCR) for LGG. Patients were closely monitored for adverse events. Eleven subjects, of whom 5 received LGG and 6 received placebo, were analyzed. No differences in VRE colony counts were seen at any time points between groups. No decline in colony counts was seen over time in subjects who received LGG.LGG was detected by PCR in all samples tested from subjects who received LGG but was only isolated in culture from 2 of 5 subjects in the LGG group. No treatment-related adverse events were seen. We demonstrated that LGG could be administered safely to patients with comorbidities and is recoverable in some patients' stool cultures. Concomitant administration of antibiotics may have resulted in an inability to recover viable organisms from stool samples, but LGG DNA could still be detected by qPCR. LGG administration did not affect VRE colonization in this study. (This study was registered at Clinicaltrials.gov under registration no. NCT00756262.) S ince their first appearance in 1988, vancomycin-resistant enterococci (VRE) have become endemic in hospitals and other health care settings throughout the United States. According to data from the National Nosocomial Infections Surveillance System, by the end of 1999 about 25% of all enterococci involved in nosocomial infections were vancomycin resistant (1). Once colonized, patients become long-term carriers (2). Patients can be colonized with VRE before they are actively infected with such organisms, and, once infected, mortality is increased (3). Elimination of the VRE carrier state is desirable to reduce transmission and thus infection, but no known treatment exists.Lactobacillus rhamnosus GG (LGG) (ATCC strain 53103) was isolated by Gorbach and Goldin in 1985 from a healthy human (4). They sought to isolate a strain based on selected characteristics thought to be required for an organism to promote health. LGG has been extensively studied in humans and has been shown to be safe and nonpathogenic (5). Studies of LGG have demonstrated decreased duration and frequency of diarrhea in children (6, 7), prevention of Clostridium difficile-associated (antibiotic-associated) diarrhea relapses (8), and prevention of travelers' diarrhea (9, 10). Large-scale clinical trials and use of LGG in yogurt and as a food supplement have also demonstrated the ...