ID

23053

Description

https://clinicaltrials.gov/ct2/show/NCT01143272 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.

Link

https://clinicaltrials.gov/ct2/show/NCT01143272

Keywords

  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
Uploaded on

June 21, 2017

DOI

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License

Creative Commons BY 4.0

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Antibiotic-associated Diarrhoea SacBo TI DRKS00000084 NCT01143272 DRKS00000084

Basic Information Registration

SacBo Registration
Description

SacBo Registration

Alias
UMLS CUI-1
C1514821
Randomization number
Description

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

Data type

integer

Alias
UMLS CUI [1]
C2986235
Enter randomization number
Description

randomization number

Data type

integer

Alias
UMLS CUI [1]
C2986235
randomization number control
Description

randomization number

Data type

integer

Alias
UMLS CUI [1]
C2986235
Patient discharge or transfer
Description

This item is necessary for registration

Data type

date

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

Similar models

Basic Information Registration

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
SacBo Registration
C1514821 (UMLS CUI-1)
randomization number
Item
Randomization number
integer
C2986235 (UMLS CUI [1])
randomization number
Item
Enter randomization number
integer
C2986235 (UMLS CUI [1])
randomization number
Item
randomization number control
integer
C2986235 (UMLS CUI [1])
patient discharge or transfer
Item
Patient discharge or transfer
date
C0030685 (UMLS CUI [1])
C0030704 (UMLS CUI [2])

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