ID

13427

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

  1. 2/5/16 2/5/16 -
  2. 2/11/16 2/11/16 -
Uploaded on

February 11, 2016

DOI

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License

Creative Commons BY-NC 3.0

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SacBo PZ: Case Report Form First Visit Randomization DRKS00000084 NCT01143272

SacBo PZ: Case Report Form First Visit Randomization NCT01143272

Default Itemgroup
Description

Default Itemgroup

Is the patient eligible for this study according to inclusion and exclusion criteria?
Description

Patient is eligible for this study according to inclusion and exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C1516637
When was the informed consent form signed?
Description

Date informed consent was signed

Data type

date

Alias
UMLS CUI [1]
C0021430
What is the randomization number?
Description

Randomization number. Please note that the randomization number cannot be changed after successful registration.

Data type

integer

Alias
UMLS CUI [1]
C2986235
Entry of randomization number
Description

Entry of randomization number

Data type

integer

Alias
UMLS CUI [1]
C2986235
Control entry of randomization number
Description

Control entry of randomization number. Note that after successful registration the items above are not filled out.

Data type

integer

Alias
UMLS CUI [1]
C2986235
What date did the randomization take place?
Description

Randomization date. Note that all information is necessary for registration.

Data type

date

Alias
UMLS CUI [1]
C0034656

Similar models

SacBo PZ: Case Report Form First Visit Randomization NCT01143272

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Patient is eligible for this study
Item
Is the patient eligible for this study according to inclusion and exclusion criteria?
boolean
C1516637 (UMLS CUI [1])
Date informed consent was signed
Item
When was the informed consent form signed?
date
C0021430 (UMLS CUI [1])
Randomization number
Item
What is the randomization number?
integer
C2986235 (UMLS CUI [1])
Entry of randomization number
Item
Entry of randomization number
integer
C2986235 (UMLS CUI [1])
Control entry of randomization number
Item
Control entry of randomization number
integer
C2986235 (UMLS CUI [1])
Randomization date
Item
What date did the randomization take place?
date
C0034656 (UMLS CUI [1])

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