Effect of Probiotic Use on Antibiotic Administration Among Care Home Residents: A Randomized Clinical Trial.

Key PointsQuestionDoes a dose of a daily oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 reduce cumulative systemic antibiotic administration days for all-cause, acute infections in care home residents? FindingsIn this randomized clinical trial that included 310 participants, this daily probiotic combination, compared with placebo, did not significantly reduce antibiotic administration over 1 year (mean cumulative antibiotic administration days, 12.9 vs 12.0). MeaningThe findings do not support the use of probiotics for reducing antibiotic administration in older adults living in care homes. ImportanceProbiotics are frequently used by residents in care homes (residential homes or nursing homes that provide residents with 24-hour support for personal care or nursing care), although the evidence on whether probiotics prevent infections and reduce antibiotic use in these settings is limited. ObjectiveTo determine whether a daily oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 compared with placebo reduces antibiotic administration in care home residents. Design, Setting, and ParticipantsPlacebo-controlled randomized clinical trial of 310 care home residents, aged 65 years and older, recruited from 23 care homes in the United Kingdom between December 2016 and May 2018, with last follow-up on October 31, 2018. InterventionsStudy participants were randomized to receive a daily capsule containing a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 (total cell count per capsule, 1.3x10(10) to 1.6x10(10)) (n=155), or daily matched placebo (n=155), for up to 1 year. Main Outcomes and MeasuresThe primary outcome was cumulative antibiotic administration days for all-cause infections measured from randomization for up to 1 year. ResultsAmong 310 randomized care home residents (mean age, 85.3 years; 66.8% women), 195 (62.9%) remained alive and completed the trial. Participant diary data (daily data including study product use, antibiotic administration, and signs of infection) were available for 98.7% randomized to the probiotic group and 97.4% randomized to placebo. Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P=.50). A total of 120 care home residents experienced 283 adverse events (150 adverse events in the probiotic group and 133 in the placebo group). Hospitalizations accounted for 94 of the events in probiotic group and 78 events in the placebo group, and deaths accounted for 33 of the events in the probiotic group and 32 of the events in the placebo group. Conclusions and RelevanceAmong care home residents in the United Kingdom, a daily dose of a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 did not significantly reduce antibiotic administration for all-cause infections. These findings do not support the use of probiotics in this setting. Trial RegistrationISRCTN Identifier:16392920 This randomized clinical trial compares the effects of daily combination probiotics (Lactobacillus and Bifidobacterium spp) vs placebo on cumulative antibiotic use for all-cause infections over 1 year among care home residents in Wales.