1. The administration of microbial preparations to inpatients at risk of developing antibiotic-associated diarrhea (AAD) or Clostridium difficile diarrhea (CDD) is no longer recommended.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Use of probiotic preparations has become an increasingly popular modality for the maintenance of bowel health. Several recent meta-analyses and reviews have discussed the beneficial effects of probiotic administration and supported its use for at-risk patients. However, these studies have varied greatly with regards to the factors studied, including differing patients characteristics, antibiotic exposure, etc. Therefore, the authors of this study sought to determine the efficacy of probiotics in preventing disease among patients at risk of AAD or CDD in a randomized, controlled setting. The study found that rates of AAD and CDD were similar between patients who were treated with an oral microbial preparation and those who received a placebo. Morbidity between the two groups was similar as well. The strength of this study lies in its design as a multicenter, randomized, double-blind, placebo-controlled, efficacy trial, as well as the fact that it is, to date, the largest study of its kind in this field. Limiting this study was the fact that the study sample was only one-fifth of the total eligible patient population and thus, the conclusions of this study might have suffered from sampling bias.
Study Author, Professor Stephen J Allen, M.D., of Swansea University talks to 2 Minute Medicine:
“Although some existing studies of the effect of probiotic supplements on AAD have suggested that these supplements might effectively reduce the incidence of AAD, these results were based mostly on small trials conducted in single locations, many of which gave inconsistent results which are difficult to incorporate in meta-analyses.
Our study is by far the largest trial so far to assess the effects on AAD of so-called probiotics – which might better be termed microbial preparations, given the uncertainty over whether they are indeed beneficial to health – and the results do not support the use of these preparations to reduce rates of AAD in older inpatients.”
In-Depth [randomized controlled trial]: The authors utilized inpatients 65 years or older who had been exposed to one or more antibiotics. Of 17,420 patients screened, 2,981 were randomized into treatment (mixed lactobacilli and bifidobacteria oral preparation) or control (sterile oral maltodextrin) groups. The patients were treated and followed for 3 weeks. AAD occurred in 10.8% of the patients in the treatment group and 10.4% of patients in the control group with a relative risk of 1.04, CI: 0.84-1.28; p = 0.71. CDD occurred in 0.8% of patients in the treatment group and 1.2% of patients in the placebo group with relative risk of 0.71, CI: 0.34-1.47; p=0.35. Morbidity between the two groups was largely similar with the exceptions of the passage of flatus (OR: 1.26 CI: 1.00–1.59; p = 0.045) and nasogastric tube insertion (OR: 8.06 CI: 1.01–64.48; p= 0.019), which were seen at higher rates in the treatment group.
By Devin Miller and Mimmie Kwong
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