ID

13422

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

Versions (3)
  1. 2/4/16 2/4/16 -
  2. 2/11/16 2/11/16 -
  3. 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 TI: Case Report Form Phone Interview Diary TI DRKS00000084 NCT01143272

English

SacBo TI: Case Report Form Phone Interview Diary TI NCT01143272

1 forms  
Current contact
Description

Current contact

Was the current contact a phone call?
Description

phone call

Data type

boolean

Was the current contact performed at an alternative date?
Description

Alternative date (14 days after prior phone call)

Data type

date

Alias
UMLS CUI [1]
C0011008
Until what date was the documentation on the current eForm performed?
Description

documentation on current eform until

Data type

date

Alias
UMLS CUI [1,1]
C0920316
UMLS CUI [1,2]
C0011008
When is the maximum end of documentation
Description

maximum end of documentation

Data type

date

Alias
UMLS CUI [1,1]
C0920316
UMLS CUI [1,2]
C0806020
What date did the current contact take place?
Description

Date of current contact

Data type

date

Alias
UMLS CUI [1]
C0011008
Stool frequency and consistency
Description

Stool frequency and consistency

What date do the following items concern?
Description

Date the next items concern including those items from the following itemgroup

Data type

date

Alias
UMLS CUI [1]
C0011008
Was the patient rehospitalized in the study hospital?
Description

Rehospitalization in study hospital

Data type

boolean

Alias
UMLS CUI [1]
C0019993
How many hard stools?
Description

Amount of hard stools

Data type

integer

Alias
UMLS CUI [1]
C0278016
How many soft stools?
Description

Amount of soft stools

Data type

integer

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

Amount of mushy or watery stools

Data type

integer

Alias
UMLS CUI [1]
C0860527
UMLS CUI [2]
C2129214
Was there no stool on this date or is the amount not known?
Description

No stool or not known

Data type

integer

Alias
UMLS CUI [1,1]
C0426642
UMLS CUI [1,2]
C0011008
Intake of investigational agent
Description

Intake of investigational agent

Did the patient take the investigational agent in the morning?
Description

Intake of investigational agent in the morning

Data type

integer

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332170
Did the patient take the investigational agent in the evening?
Description

Intake of the investigational agent in the evening

Data type

integer

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0587117
Did the patient use any laxatives?
Description

Use of laxatives

Data type

integer

Alias
UMLS CUI [1]
C0282090
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Similar models

SacBo TI: Case Report Form Phone Interview Diary TI NCT01143272

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Current contact
phone call
Item
Was the current contact a phone call?
boolean
Alternative date
Item
Was the current contact performed at an alternative date?
date
C0011008 (UMLS CUI [1])
documentation until
Item
Until what date was the documentation on the current eForm performed?
date
C0920316 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
end of documentation
Item
When is the maximum end of documentation
date
C0920316 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Date of current contact
Item
What date did the current contact take place?
date
C0011008 (UMLS CUI [1])
Item Group
Stool frequency and consistency
Date
Item
What date do the following items concern?
date
C0011008 (UMLS CUI [1])
Rehospitalization in study hospital
Item
Was the patient rehospitalized in the study hospital?
boolean
C0019993 (UMLS CUI [1])
hard stool
Item
How many hard stools?
integer
C0278016 (UMLS CUI [1])
soft stool
Item
How many soft stools?
integer
C0577115 (UMLS CUI [1])
mushy or watery stool
Item
How many mushy or watery stools?
integer
C0860527 (UMLS CUI [1])
C2129214 (UMLS CUI [2])
Item
Was there no stool on this date or is the amount not known?
integer
C0426642 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
no stool or not known
Code List
Was there no stool on this date or is the amount not known?
CL Item
no stool (1)
CL Item
not known (2)
Item Group
Intake of investigational agent
Item
Did the patient take the investigational agent in the morning?
integer
C0013230 (UMLS CUI [1,1])
C0332170 (UMLS CUI [1,2])
in the morning
Code List
Did the patient take the investigational agent in the morning?
CL Item
yes (1)
CL Item
no (2)
CL Item
not known (3)
Item
Did the patient take the investigational agent in the evening?
integer
C0013230 (UMLS CUI [1,1])
C0587117 (UMLS CUI [1,2])
in the evening
Code List
Did the patient take the investigational agent in the evening?
CL Item
yes (1)
CL Item
no (2)
CL Item
not known (3)
Item
Did the patient use any laxatives?
integer
C0282090 (UMLS CUI [1])
Use of laxatives
Code List
Did the patient use any laxatives?
CL Item
yes (1)
CL Item
no (2)
CL Item
not known (3)
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