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Randomized Controlled Trial
. 2020 Jul 7;324(1):47-56.
doi: 10.1001/jama.2020.8556.

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

Christopher C Butler  1 , Mandy Lau  2 , David Gillespie  2 , Eleri Owen-Jones  2 , Mark Lown  3 , Mandy Wootton  4 , Philip C Calder  5 , Antony J Bayer  6 , Michael Moore  3 , Paul Little  3 , Jane Davies  2 , Alison Edwards  2 , Victoria Shepherd  2 , Kerenza Hood  2 , F D Richard Hobbs  1 , Mina Davoudianfar  1 , Heather Rutter  1 , Helen Stanton  2 , Rachel Lowe  2 , Richard Fuller  3 , Nick A Francis  3
Affiliations
Randomized Controlled Trial

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

Christopher C Butler et al. JAMA. .

Abstract

Importance: Probiotics 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.

Objective: To 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 participants: Placebo-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.

Interventions: Study 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, 1.3 × 1010 to 1.6 × 1010) (n = 155), or daily matched placebo (n = 155), for up to 1 year.

Main outcomes and measures: The primary outcome was cumulative antibiotic administration days for all-cause infections measured from randomization for up to 1 year.

Results: Among 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 relevance: Among 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 registration: ISRCTN Identifier:16392920.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Butler reported grants from the Efficacy and Mechanism Evaluation (EME) program, which is funded by the Medical Research Council (MRC) and the National Institute for Health Research (NIHR), being part of a publicly funded research consortia that includes industrial partners, and funding from the NIHR Health Protection Research Unit (HPRU) in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford, Oxford, UK, in partnership with Public Health England during the conduct of the study; grants from NIHR Health, the NIHR Health Technology Assessment Programme, Roche Molecular Diagnostics, NIHR Health Protection Research Unit on Health Care Associated Infections and Antimicrobial Resistance; and personal fees from Pfizer, Roche Molecular Diagnostics (advisory board participation), and Janssen Pharmaceuticals (advisory board participation) outside the submitted work; and being a salaried general medical practitioner in the Cwm Taf Morgannwg University Health Board, an NIHR senior investigator, and clinical director of the University of Oxford Primary Care and Vaccines Clinical Trials Collaboration and the NIHR Oxford Community Medical Technology and Invitro Diagnostics Co-operative. Dr Hobbs reported partial funding from the NIHR School for Primary Care Research, the NIHR Collaboration for Leadership in Health Research and Care Oxford, the NIHR Oxford Biomedical Research Centre, and the NIHR Oxford MedTech and In-Vitro Diagnostics Co-operative. Dr Gillespie reported grants from NIHR/MRC EME during the conduct of the study. Dr Owen-Jones reported grants from NIHR EME during the conduct of the study. Dr Lown reported grants from NIHR during the conduct of the study. Dr Calder reported grants from NIHR during the conduct of the study; personal fees from Chr Hansen, and nonfinancial support from Chr Hansen outside the submitted work. Dr Bayer reported grants from NIHR during the conduct of the study. Dr Moore reported grants from NIHR during the conduct of the study. Dr Shepherd reported grants from NIHR EME during the conduct of the study. Dr Hood reported grants from NIHR EME during the conduct of the study. Dr Lowe reported grants from NIHR EME and nonfinancial support from Chr Hansen during the conduct of the study. Dr Francis reported grants from NIHR/MRC EME during the conduct of the study. No other disclosures were reported.

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Figure.
Figure.. Enrollment, Randomization, and Follow-up of Care Home Residents
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