ID

13544

Descrição

Antibiotic-associated diarrhoea (AAD) is a frequent condition in hospitalised patients receiving antibiotic treatment. The same is true for Clostridium difficile-associated diarrhoea (CDAD) with even more grave consequences of increased morbidity and mortality. The development and evaluation of preventive strategies is one key public health challenge. In the absence of clinically evaluated alternatives, probiotics have been suggested to be beneficial for the prevention of AAD and CDAD. However, data have so far been inconclusive and recently published meta-analyses strongly recommended large state-of-the-art clinical trials on probiotic substances for the prevention of AAD and CDAD. Since the efficacy, side-effects and modes of action of different probiotic bacteria and yeast are strain specific, benefits and risks cannot be generalised. The non-pathogenic yeast Saccharomyces cerevisiae var. boulardii (Sac. boulardii) is considered the most promising probiotic substance for the prevention of AAD and CDAD. We carry out a randomised, placebo controlled, double blind multicentre clinical trial to evaluate Sac. boulardii for the indication of prevention of AAD and CDAD in 1520 adult, hospitalised patients.

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  1. 15/02/2016 15/02/2016 -
Titular dos direitos

CC BY-NC 3.0

Transferido a

15 de fevereiro de 2016

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Creative Commons BY-NC 3.0

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SacBo PZ: Case Report Form AE Termination Signature DRKS00000084 NCT01143272

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Please enter any relevant information on discrepancy from the intended examination and treatment measures or examination and treatment times if necessary and substantiate (on comment per line)

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Alias
UMLS CUI [1]
C0947611

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SacBo PZ: Case Report Form AE Termination Signature Comment (optional)

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C0947611 (UMLS CUI [1])

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