ID

13434

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 (2)
  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 PZ: Case Report Form Hospitalization Documentation Diarrhea - AAD - CDAD DRKS00000084 NCT01143272

English

SacBo PZ: Case Report Form Hospitalization Documentation Diarrhea - AAD - CDAD NCT01143272

1 forms  
Default Itemgroup
Description

Default Itemgroup

What date did the diarrhea/AAD/CDAD occur?
Description

Date diarrhea/AAD/CDAD occured

Data type

date

Alias
UMLS CUI [1]
C0011991
UMLS CUI [2]
C0578159
UMLS CUI [3]
C0235952
What is the number of the episode?
Description

Episode

Data type

integer

Alias
UMLS CUI [1]
C0332189
What date was the stool sample acquired to be passed on to the BNI?
Description

Date the stool sample was acquired to be passed on to the BNI

Data type

date

Alias
UMLS CUI [1,1]
C0420729
UMLS CUI [1,2]
C0011008
Was there antibiotic-assoiated diarrhea as a clinical diagnosis?
Description

AAD: clinical diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0578159
Did antibiotic-associated diarrhea occur and were microbes found?
Description

AAD: microbes

Data type

boolean

Alias
UMLS CUI [1]
C0578159
What kind of microbes were found?
Description

Microbes

Data type

text

Alias
UMLS CUI [1]
C0445623
Did clostridium difficile associated diarrhea occur and was the diagnosis confirmed by stool culture?
Description

CDAD: Confirmation by stool culture

Data type

boolean

Alias
UMLS CUI [1]
C0235952
UMLS CUI [2]
C0430414
Did CDAD occur and was the diagnosis confirmed by finding Toxin A and/or Toxin B?
Description

CDAD: Confirmation by toxin A and/or toxin B

Data type

boolean

Alias
UMLS CUI [1]
C0314765
Did CDAD occur that was confirmed by endoscopy?
Description

CDAD: Confirmation by endoscopy

Data type

boolean

Alias
UMLS CUI [1]
C0235952
UMLS CUI [2]
C0014245
Did CDAD occur and was the diagnosis confirmed by methods of molecular biology?
Description

CDAD: Confirmation by molecular biology

Data type

boolean

Alias
UMLS CUI [1]
C0235952
UMLS CUI [2]
C0026376
Did diarrhea occur that was exclusively diarrhea other than AAD or CDAD?
Description

Other diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0011991
Clinical diagnosis
Description

Clinical diagnosis

Was there blood in the stool?
Description

Bloody stool

Data type

integer

Alias
UMLS CUI [1]
C0018932
Was there abdominal pain or cramps?
Description

Abdominal pain/cramp

Data type

integer

Alias
UMLS CUI [1]
C0000737
UMLS CUI [2]
C0000729
Was there dehydration?
Description

Dehydration

Data type

integer

Alias
UMLS CUI [1]
C0011175
Was there fever?
Description

Fever

Data type

integer

Alias
UMLS CUI [1]
C0015967
Did the patient receive any medication?
Description

Medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Conservative or surgical therapy for AAD/CDAD
Description

Conservative or surgical therapy for AAD/CDAD

Was there any further conservative or surgical therapy necessary for AAD/CDAD?
Description

Further therapy for AAD/CDAD. (Antibiotics should only be documented as "medication subject to documentation")

Data type

boolean

Alias
UMLS CUI [1,1]
C0578159
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0235952
UMLS CUI [2,2]
C0087111
If there was further treatment necessary please specify:
Description

If there was further treatment necessary please specify: (1 treatment per line)

Data type

text

Alias
UMLS CUI [1,1]
C0578159
UMLS CUI [1,2]
C0087111
UMLS CUI [2,1]
C0235952
UMLS CUI [2,2]
C0087111
Further episode of diarrhea/AAD/CDAD
Description

Further episode of diarrhea/AAD/CDAD

Was there any further episode of diarrhea/AAD/CDAD or was another stool sample acquired?
Description

Further episode of diarrhea/AAD/CDAD or further stool sample acquired? According to the study protocol there must be at least 5 days without any symptoms between 2 episodes of diarrhea.

Data type

boolean

Alias
UMLS CUI [1]
C0011991
UMLS CUI [2]
C0578159
UMLS CUI [3]
C0235952
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Similar models

SacBo PZ: Case Report Form Hospitalization Documentation Diarrhea - AAD - CDAD NCT01143272

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Default Itemgroup
Date diarrhea/AAD/CDAD occured
Item
What date did the diarrhea/AAD/CDAD occur?
date
C0011991 (UMLS CUI [1])
C0578159 (UMLS CUI [2])
C0235952 (UMLS CUI [3])
Episode
Item
What is the number of the episode?
integer
C0332189 (UMLS CUI [1])
Date the stool sample was acquired to be passed on to the BNI
Item
What date was the stool sample acquired to be passed on to the BNI?
date
C0420729 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
AAD: clinical diagnosis
Item
Was there antibiotic-assoiated diarrhea as a clinical diagnosis?
boolean
C0578159 (UMLS CUI [1])
AAD: microbes
Item
Did antibiotic-associated diarrhea occur and were microbes found?
boolean
C0578159 (UMLS CUI [1])
Microbes
Item
What kind of microbes were found?
text
C0445623 (UMLS CUI [1])
CDAD: Confirmation by stool culture
Item
Did clostridium difficile associated diarrhea occur and was the diagnosis confirmed by stool culture?
boolean
C0235952 (UMLS CUI [1])
C0430414 (UMLS CUI [2])
CDAD: Toxin A and/or Toxin B
Item
Did CDAD occur and was the diagnosis confirmed by finding Toxin A and/or Toxin B?
boolean
C0314765 (UMLS CUI [1])
CDAD: Confirmation by endoscopy
Item
Did CDAD occur that was confirmed by endoscopy?
boolean
C0235952 (UMLS CUI [1])
C0014245 (UMLS CUI [2])
CDAD: Confirmation by molecular biology
Item
Did CDAD occur and was the diagnosis confirmed by methods of molecular biology?
boolean
C0235952 (UMLS CUI [1])
C0026376 (UMLS CUI [2])
Other diarrhea
Item
Did diarrhea occur that was exclusively diarrhea other than AAD or CDAD?
boolean
C0011991 (UMLS CUI [1])
Item Group
Clinical diagnosis
Item
Was there blood in the stool?
integer
C0018932 (UMLS CUI [1])
Blood in stool
Code List
Was there blood in the stool?
CL Item
yes (1)
CL Item
no (2)
CL Item
not known (3)
Item
Was there abdominal pain or cramps?
integer
C0000737 (UMLS CUI [1])
C0000729 (UMLS CUI [2])
Abdominal pain/cramp
Code List
Was there abdominal pain or cramps?
CL Item
yes (1)
CL Item
no (2)
CL Item
not known (3)
Item
Was there dehydration?
integer
C0011175 (UMLS CUI [1])
Dehydration
Code List
Was there dehydration?
CL Item
yes (1)
CL Item
no (2)
CL Item
not known (3)
Item
Was there fever?
integer
C0015967 (UMLS CUI [1])
Fever
Code List
Was there fever?
CL Item
yes (1)
CL Item
no (2)
CL Item
not known (3)
Medication
Item
Did the patient receive any medication?
boolean
C0013227 (UMLS CUI [1])
Item Group
Conservative or surgical therapy for AAD/CDAD
Further therapy for AAD/CDAD
Item
Was there any further conservative or surgical therapy necessary for AAD/CDAD?
boolean
C0578159 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0235952 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Treatment specification
Item
If there was further treatment necessary please specify:
text
C0578159 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0235952 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Item Group
Further episode of diarrhea/AAD/CDAD
Further episode of diarrhea/AAD/CDAD
Item
Was there any further episode of diarrhea/AAD/CDAD or was another stool sample acquired?
boolean
C0011991 (UMLS CUI [1])
C0578159 (UMLS CUI [2])
C0235952 (UMLS CUI [3])
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