ID

13429

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. 2/8/16 2/8/16 -
  2. 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 PZ: Case Report Form First Visit CRP, Leukocytes DRKS00000084 NCT01143272

SacBo PZ: Case Report Form First Visit CRP, Leukocytes NCT01143272

Examination date
Description

Examination date

What date did the examination take place?
Description

Examination date. In the time intervall: a) 4 days before the first dose of the antibiotic initially used until b) the day of the first dose of the antibiotic initially used

Data type

date

Alias
UMLS CUI [1]
C0260877
CRP
Description

CRP

Alias
UMLS CUI-1
C0201657
What was the CRP value?
Description

CRP value

Data type

integer

Alias
UMLS CUI [1]
C0201657
Was the CRP measurement not performed?
Description

CRP measurement not done

Data type

boolean

Alias
UMLS CUI [1,1]
C0201657
UMLS CUI [1,2]
C1272696
Is the unit mg/L?
Description

Unit mg/L

Data type

boolean

Alias
UMLS CUI [1]
C0439268
Is the unit mg/dl?
Description

Unit mg/dL

Data type

boolean

Alias
UMLS CUI [1]
C0439269
Was a different unit used?
Description

Different unit

Data type

boolean

Alias
UMLS CUI [1]
C1519795
What was the unit that was used?
Description

Different unit specification

Data type

text

Alias
UMLS CUI [1]
C1519795
Leukocytes
Description

Leukocytes

Alias
UMLS CUI-1
C0023516
What was the measured leukocyte value?
Description

Leukocytes value

Data type

text

Alias
UMLS CUI [1]
C0023508
Was the leukocyte measurement not performed?
Description

Leukocyte measurement not performed

Data type

boolean

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1272696
Is the unit 10**9/L? 10**9/L equals: 1000/mcL, 10*3/mcL, /nL, G/L, Gpt/L, Giga/L
Description

Unit 10**9/L

Data type

boolean

Alias
UMLS CUI [1]
C0456615
Is the unit /mcL = /mm3?
Description

Unit /mcL = /mm3

Data type

boolean

Alias
UMLS CUI [1]
C1300557
Was a different unit used?
Description

Different unit

Data type

boolean

Alias
UMLS CUI [1]
C1519795
What was the unit that was used?
Description

Different unit specification

Data type

text

Alias
UMLS CUI [1]
C1519795

Similar models

SacBo PZ: Case Report Form First Visit CRP, Leukocytes NCT01143272

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Examination date
Examination date
Item
What date did the examination take place?
date
C0260877 (UMLS CUI [1])
Item Group
CRP
C0201657 (UMLS CUI-1)
CRP
Item
What was the CRP value?
integer
C0201657 (UMLS CUI [1])
CRP measurement not done
Item
Was the CRP measurement not performed?
boolean
C0201657 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Unit mg/L
Item
Is the unit mg/L?
boolean
C0439268 (UMLS CUI [1])
Unit mg/dL
Item
Is the unit mg/dl?
boolean
C0439269 (UMLS CUI [1])
Different unit
Item
Was a different unit used?
boolean
C1519795 (UMLS CUI [1])
Different unit specification
Item
What was the unit that was used?
text
C1519795 (UMLS CUI [1])
Item Group
Leukocytes
C0023516 (UMLS CUI-1)
Leukocytes value
Item
What was the measured leukocyte value?
text
C0023508 (UMLS CUI [1])
Leukocyte measurement not performed
Item
Was the leukocyte measurement not performed?
boolean
C0023508 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Unit 10**9/L
Item
Is the unit 10**9/L? 10**9/L equals: 1000/mcL, 10*3/mcL, /nL, G/L, Gpt/L, Giga/L
boolean
C0456615 (UMLS CUI [1])
Unit /mcL = /mm3
Item
Is the unit /mcL = /mm3?
boolean
C1300557 (UMLS CUI [1])
Different unit
Item
Was a different unit used?
boolean
C1519795 (UMLS CUI [1])
Different unit specification
Item
What was the unit that was used?
text
C1519795 (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