A Pilot Randomized Trial to Determine the Tolerability of a Probiotic in Patients Colonized with Vancomycin-Resistant Enterococcus

Abstract

Background: Vancomycin-resistant enterococcus (VRE) is an organism of major concern in hospital settings because of transmission in healthcare facilities. Purpose: To examine the feasibility and tolerability of a probiotic, VSL#, to reduce colonization among subjects at risk of VRE infection. Methods: Randomized double blind placebo-controlled trial. Results: Fifty subjects were enrolled and randomized. Over half of the subjects were solid organ transplant recipients and/or immune compromised. The probiotic was well tolerated in the study population except for minor side effects such as nausea and bloating. A 30% withdrawal rate in this population was found. Conclusion: Probiotics were well tolerated in our study population of largely immune compromised subjects with multiple comorbidities. Adherence to the intervention was low but not unexpected due to complexity of the of the study population. Future studies should examine ways to improve adherence to probiotics and subject retention in treatment trials in immune compromised patients.