Study findings don’t support prophylactic probiotics in the assisted living care setting

Daily, oral probiotic use was not associated with reduced antibiotic treatment among elderly people living in assisted care facilities in a randomized, clinical trial from the United Kingdom.

Patients in the probiotic arm of the trial had slightly higher antibiotic use than those in the control arm of the study, and probiotic use was not found to be beneficial with regard to other study endpoints, including duration of infection, patient well-being, hospitalization, death and antibiotic-associated diarrhea.

Researcher Christoper C. Butler, MD, of the University of Oxford, UK, and colleagues, concluded that the findings, published July 7 in JAMA, do not support the use of probiotics for prevention in the elderly, congregant-living population, and they do “not rule out harm from probiotics.”

In a telephone interview with BreakingMED, Butler said even if probiotic use is safe, the combination probiotics used in the study did not benefit older adults living in assisted living.

“We were hopeful that this would prove to be a cheap, safe intervention to reduce antibiotic use and infections and all the problems that go along with infections in the elderly,” he said. “In our study, the people taking probiotics had more episodes of lower respiratory tract infection, but we can’t say that this was related to probiotic use. All we can really say is that we saw no evidence of benefit.”

In the introduction to their study, Butler and colleagues noted that the probiotic market totaled more than $34 billion U.S. dollars annually in 2015, with projections suggesting a market size of $64 billion by 2023.

The U.S. hospital and nursing home market for probiotics was estimated to be $92.4 million in 2016, with an estimated compounded annual growth rate of 9.3% projected until 2025.

“Probiotics are often promoted for health indications, and may be an inexpensive and safe intervention to reduce antibiotic use and resistance through preventing infections,” the researchers wrote.

Their study included 310 elderly care home residents (median age, 85.3 years, 66.8% female), recruited from 23 congregant-living facilities in the United Kingdom between December of 2016 and late October 2018.

Study participants were randomized to receive a daily oral capsule containing the combination probiotic Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 (n=155 participants) or daily-match placebo (n=155) for up to a year.

The primary study outcome was cumulative antibiotic administration days for all-cause infections from randomization to up to a year.

Secondary outcomes included total number of days of antibiotic administration for each infection category recorded in care home records, skin and soft tissue infections, number and duration of hospital stays, deaths, duration of diarrhea when oral antibiotics were taken and not taken, and incidence of C. difficile infection.

Daily diaries — used to record diary data product use, antibiotic administration, and signs of infection — were available for 98.7% participants randomized to the probiotic group and 97.4% randomized to placebo.

Among the main findings:

  • Residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0-18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0-6.95).
  • The absolute difference was 0.9 days (95% CI, –3.25-5.05 days), and the adjusted incidence rate ratio (IRR) was 1.13 (95% CI, 0.79-1.63; P=0.05).
  • Residents receiving the probiotic combination were administered significantly more antibiotics for lower respiratory tract infections than those randomized to the placebo group (mean 6.2 days versus 4.0 days (absolute difference 2.2 days; 95% CI -0.41-4.81 days; adjusted IRR, 1.42; 95% CI, 1.05-1.93; P=0.02)
  • 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.

Study limitations included shorter follow-up than anticipated for some patients due to longer than expected study set-up and a higher than expected prevalence of probiotics in stool cultures at baseline.

The researchers added that the study’s lower than expected event rate may have rendered it under-powered to detect statistical significance for the difference in the primary outcome.

“Among care home residents in the UK, a daily oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 did not significantly reduce antibiotic administration for all-cause infections. The findings do not support the use of probiotics in this setting,” they concluded.

  1. Daily probiotic use was not associated with reduced antibiotic treatment in a randomized clinical trial involving elderly people living in assisted care facilities.

  2. Patients in the probiotic arm of the trial had slightly higher antibiotic use than those in the control arm of the study, and a higher incidence of death from infection.

Salynn Boyles, Contributing Writer, BreakingMED™

Funding for this research was provided by the United Kingdom’s Efficacy and Mechanism Evaluation (EME) program, which is funded by the Medical Research Council and National Institute for Health Research (NIHR) and industry partners.

Researcher Christopher C. Butler reported receiving personal fees from Pfizer, Roche Molecular Diagnostic and Janssen Pharmaceuticals unrelated to this research. Several other researchers reported receiving grant support from NIHR during the conduct of the study.

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Topic ID: 398,494,494,730,188,125,190,255,925