ID

13318

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. 04/02/2016 04/02/2016 -
  2. 11/02/2016 11/02/2016 -
  3. 11/02/2016 11/02/2016 -
  4. 21/06/2017 21/06/2017 - Martin Dugas
Titular dos direitos

CC BY-NC 3.0

Transferido a

4 de fevereiro de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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SacBo TI Basic Information Registration

SacBo TI Basic Information Registration

SacBo Registration
Descrição

SacBo Registration

Randomization number
Descrição

Please note: The randomization number cannot be changed after successful registration!

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C0034656
Enter randomization number
Descrição

enter randomization number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C0034656
randomization number control
Descrição

randomization number

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C0034656
Patient discharge or transfer
Descrição

This item is necessary for registration

Tipo de dados

date

Alias
UMLS CUI [1]
C0030685
UMLS CUI [2]
C0030704

Similar models

SacBo TI Basic Information Registration

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
SacBo Registration
randomization number
Item
Randomization number
integer
C0030705 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
enter randomization number
Item
Enter randomization number
integer
C0030705 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
randomization number
Item
randomization number control
integer
C0030705 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
patient discharge or transfer
Item
Patient discharge or transfer
date
C0030685 (UMLS CUI [1])
C0030704 (UMLS CUI [2])

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