ID

13432

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. 2/9/16 2/9/16 -
  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: Case Report Form Hospitalization Patient Diary DRKS00000084 NCT01143272

SacBo: Case Report Form Hospitalization Patient Diary NCT01143272

Starting date of documentation
Description

Starting date of documentation

When did documentation start?
Description

Starting date of documentation. 1) for first hospitalization documentation begins with the day of the first dose of the antibiotic initially used 2) for rehospitalization documentation begins with the first day of rehospitalization (for out-patient readmission there is no documentation necessary)

Data type

date

Alias
UMLS CUI [1,1]
C0920316
UMLS CUI [1,2]
C0808070
Stool frequency and consistency
Description

Stool frequency and consistency

What day do the following items concern?
Description

Day

Data type

text

What date is it?
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
How many hard stools on this day?
Description

Hard Stool

Data type

integer

Alias
UMLS CUI [1]
C0278016
Soft Stool
Description

Soft Stool

Data type

integer

Alias
UMLS CUI [1]
C0577115
How many mushy or watery stools on this day?
Description

Mushy or watery stool

Data type

integer

Alias
UMLS CUI [1]
C0860527
UMLS CUI [2]
C2129214
Was there no stool on this day or is the number of stools not known?
Description

No stool or not known

Data type

integer

Alias
UMLS CUI [1]
C0015733
UMLS CUI [2]
C0439673
Until what date is there documentation in the diary?
Description

Diary duration

Data type

date

Alias
UMLS CUI [1,1]
C0920316
UMLS CUI [1,2]
C0806020
New page
Description

New page

Do you want to start a new page in order to continue the patient diary?
Description

New page

Data type

boolean

Similar models

SacBo: Case Report Form Hospitalization Patient Diary NCT01143272

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Starting date of documentation
Starting date of documentation
Item
When did documentation start?
date
C0920316 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item Group
Stool frequency and consistency
Day
Item
What day do the following items concern?
text
Date
Item
What date is it?
date
C0011008 (UMLS CUI [1])
Hard Stool
Item
How many hard stools on this day?
integer
C0278016 (UMLS CUI [1])
Soft Stool
Item
Soft Stool
integer
C0577115 (UMLS CUI [1])
Mushy or watery stool
Item
How many mushy or watery stools on this day?
integer
C0860527 (UMLS CUI [1])
C2129214 (UMLS CUI [2])
Item
Was there no stool on this day or is the number of stools not known?
integer
C0015733 (UMLS CUI [1])
C0439673 (UMLS CUI [2])
Code List
Was there no stool on this day or is the number of stools not known?
CL Item
no stool (1)
CL Item
unknown (2)
Diary duration
Item
Until what date is there documentation in the diary?
date
C0920316 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
New page
New page
Item
Do you want to start a new page in order to continue the patient diary?
boolean

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