MedicalResearch.com: What are the main findings of the study?
Answer: Overall, diarrhoea occurred in just over 10% participants and diarrhoea caused by C. difficile in about 1%. These outcomes were equally common in those taking the microbial preparation and those taking placebo.
Other outcomes (e.g. common GI symptoms, length of hospital stay, quality of life) were also much the same in the two groups. So, there was no evidence that the microbial preparation had prevented diarrhoea or had led to any other health benefit.
In agreement with previous research, serious adverse events were also similar in the two groups – so we found no evidence that the microbial preparation caused any harm.
MedicalResearch.com: Were any of the findings unexpected?
Answer: We had been encouraged by the underlying rationale for using microbial preparations (“probiotics“) for AAD and the evidence from the several smaller trials. Therefore, we were surprised by the lack of evidence for any health benefit from the microbial preparation in our trial – but this finding was clear.
MedicalResearch.com: What should clinicians and patients take away from your report?
Answer: Our findings should discourage the use of microbial preparations for the prevention of the diarrhoea that complicates antibiotic treatment – until further evidence is available.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Answer: Our findings highlight the importance of undertaking large, pragmatic trials to determine whether or not microbial preparations are “probiotic” for specific health indications.
More research is needed to identify the underlying mechanisms of the diarrhoea associated with antibiotic use. A major problem is that there is a potentially very large number indeed of “probiotics” and probiotic combinations that could be evaluated in clinical trials. Therefore, we would advise against clinical trials of other microbial preparations – unless there is some reliable evidence (e.g. from lab studies) that a specific preparation may directly address known underlying mechanisms.
Lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea and Clostridium difficile diarrhoea in older inpatients (PLACIDE): a randomised, double-blind, placebo-controlled, multicentre trial
Prof Stephen J Allen MD,Kathie Wareham MPH,Duolao Wang PhD,Caroline Bradley MSc,Hayley Hutchings PhD,Wyn Harris FRCP,Anjan Dhar MD,Helga Brown FRCP,Alwyn Foden FRCP,Prof Michael B Gravenor DPhil,Prof Dietrich Mack MD
The Lancet – 8 August 2013