ID

13425

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.

Palavras-chave

  1. 05/02/2016 05/02/2016 -
  2. 11/02/2016 11/02/2016 -
Transferido a

11 de fevereiro de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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SacBo TI: Case Report Form End Of Study Signature DRKS00000084 NCT01143272

SacBo TI: Case Report Form End Of Study Signature NCT01143272

electronic signature
Descrição

electronic signature

Is the integrity and the accuracy of the data confirmed?
Descrição

confirmation of the integrity and the accuracy of the data

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0521091
UMLS CUI [1,2]
C0872340

Similar models

SacBo TI: Case Report Form End Of Study Signature NCT01143272

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
electronic signature
confirmation of the integrity and the correctness of the data
Item
Is the integrity and the accuracy of the data confirmed?
boolean
C0521091 (UMLS CUI [1,1])
C0872340 (UMLS CUI [1,2])

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