ID

13428

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 Patient Data DRKS00000084 NCT01143272

SacBo PZ: Case Report Form First Visit Patient Data NCT01143272

Patient Data
Description

Patient Data

Alias
UMLS CUI-1
C2707520
Whats is the patient's date of birth?
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Whats is the patient's gender?
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
What is the patient's body height?
Description

Patient body height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
What is the patient's body weight?
Description

Patient body weight

Data type

integer

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Antibiotic initially used
Description

Antibiotic initially used

When was the first dose applied?
Description

Antibiotic first dose. Entry is necessary for registration.

Data type

date

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0011008
First dose of investigational drug
Description

First dose of investigational drug

When was the first dose of the investigational drug applied?
Description

First dose of investigational drug

Data type

date

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C3174092
UMLS CUI [1,3]
C0205435
UMLS CUI [1,4]
C0011008

Similar models

SacBo PZ: Case Report Form First Visit Patient Data NCT01143272

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Patient Data
C2707520 (UMLS CUI-1)
Date of birth
Item
Whats is the patient's date of birth?
date
C0421451 (UMLS CUI [1])
Item
Whats is the patient's gender?
integer
C0079399 (UMLS CUI [1])
Code List
Whats is the patient's gender?
CL Item
male (1)
CL Item
female (2)
Height
Item
What is the patient's body height?
integer
C0005890 (UMLS CUI [1])
Weight
Item
What is the patient's body weight?
integer
C0005910 (UMLS CUI [1])
Item Group
Antibiotic initially used
Antibiotic first dose
Item
When was the first dose applied?
date
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
First dose of investigational drug
First dose of investigational drug
Item
When was the first dose of the investigational drug applied?
date
C0013230 (UMLS CUI [1,1])
C3174092 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])

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