ID

13418

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 -
  3. 2/11/16 2/11/16 -
Uploaded on

February 11, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

SacBo TI: Case Report Form End Of Study Code Box DRKS00000084 NCT01143272

SacBo TI: Case Report Form End Of Study Code Box NCT01143272

Baseline and follow-up boxes
Description

Baseline and follow-up boxes

What is the code of the box?
Description

Code

Data type

text

Alias
UMLS CUI [1]
C0805701
How many capsules are left?
Description

number of capsules left

Data type

integer

Alias
UMLS CUI [1]
C0006935

Similar models

SacBo TI: Case Report Form End Of Study Code Box NCT01143272

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Baseline and follow-up boxes
Code
Item
What is the code of the box?
text
C0805701 (UMLS CUI [1])
number of capsules left
Item
How many capsules are left?
integer
C0006935 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial