ID

13318

Description

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.

Keywords

Versions (4)
  1. 2/4/16 2/4/16 -
  2. 2/11/16 2/11/16 -
  3. 2/11/16 2/11/16 -
  4. 6/21/17 6/21/17 - Martin Dugas
Copyright Holder

CC BY-NC 3.0

Uploaded on

February 4, 2016

DOI

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License

Creative Commons BY-NC 3.0
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SacBo TI Basic Information Registration

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SacBo TI Basic Information Registration

1 forms  
SacBo Registration
Description

SacBo Registration

Randomization number
Description

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

Data type

integer

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

enter randomization number

Data type

integer

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

randomization number

Data type

integer

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

This item is necessary for registration

Data type

date

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

SacBo TI Basic Information Registration

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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