ID

23709

Description

Responsible Party: Stephan Ehrhardt, Lead investigator, Bernhard Nocht Institute for Tropical Medicine ClinicalTrials.gov Identifier: NCT01143272 History of Changes Other Study ID Numbers: BNI-2009-01 2009-017374 [Titel anhand dieser ISBN in Citavi-Projekt übernehmen] -20 ( EudraCT Number ) ISRCTN01005546 ( Registry Identifier: ISRCTN, http://www.controlled-trials.com/ISRCTN01005546 ) DRKS00000084 ( Registry Identifier: Deutsches Register Klinischer Studien ) Study First Received: June 11, 2010 Results First Received: March 17, 2016 Last Updated: June 7, 2016 Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea (SacBo) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01143272

Link

http://www.controlled-trials.com/ISRCTN01005546

Keywords

Versions (1)
  1. 7/11/17 7/11/17 -
Uploaded on

July 11, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
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.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Antibiotic-associated Diarrhoea NCT01143272 DRKS00000084

English

Eligibility Antibiotic-associated Diarrhoea NCT01143272 DRKS00000084

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Adult patient (≥ 18 years)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Patient hospitalized
Description

Hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0019993
Patient receives systemic antibiotic treatment
Description

Systemic antibiotic treatment

Data type

boolean

Alias
UMLS CUI [1]
C3540704
Patient contractually capable
Description

Legal competency

Data type

boolean

Alias
UMLS CUI [1]
C0680554
Patient able to follow study procedures
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Informed consent of patient
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
allergy against yeast and/or Perenterol® forte und/oder placebos containing Saccharomyces cerevisiae HANSEN CBS 5926, lactose-monohydrate, magnesium stearate, gelatine, sodium dodecyl sulfate, titan dioxide, microcrystalline cellulose.
Description

Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0020517
Central venous catheter
Description

Central venous catheter

Data type

boolean

Alias
UMLS CUI [1]
C1145640
Immunosuppression
Description

Immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0021079
Diarrhoea and/or chronic diarrhoea
Description

Diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0011991
Regular intake of Perenterol®, Perenterol® forte oder Yomogi® in the last seven days before the start of the study
Description

Pharmacotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0013216
Systemic antimycotic treatment
Description

Systemic antimycotic treatment

Data type

boolean

Alias
UMLS CUI [1]
C3653762
Systemic antibiotic treatment within the last 6 weeks
Description

Prior Antibiotic Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C1514463
No protection against conception, pregnancy, or lactation
Description

Gynaecological Status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
Simultaneous participation in other clinical trials
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Back to the top of the page

Similar models

Eligibility Antibiotic-associated Diarrhoea NCT01143272 DRKS00000084

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Adult patient (≥ 18 years)
boolean
C0001779 (UMLS CUI [1])
Hospitalization
Item
Patient hospitalized
boolean
C0019993 (UMLS CUI [1])
Systemic antibiotic treatment
Item
Patient receives systemic antibiotic treatment
boolean
C3540704 (UMLS CUI [1])
Legal competency
Item
Patient contractually capable
boolean
C0680554 (UMLS CUI [1])
Compliance
Item
Patient able to follow study procedures
boolean
C1321605 (UMLS CUI [1])
Informed consent
Item
Informed consent of patient
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Hypersensitivity
Item
allergy against yeast and/or Perenterol® forte und/oder placebos containing Saccharomyces cerevisiae HANSEN CBS 5926, lactose-monohydrate, magnesium stearate, gelatine, sodium dodecyl sulfate, titan dioxide, microcrystalline cellulose.
boolean
C0020517 (UMLS CUI [1])
Central venous catheter
Item
Central venous catheter
boolean
C1145640 (UMLS CUI [1])
Immunosuppression
Item
Immunosuppression
boolean
C0021079 (UMLS CUI [1])
Diarrhea
Item
Diarrhoea and/or chronic diarrhoea
boolean
C0011991 (UMLS CUI [1])
Pharmacotherapy
Item
Regular intake of Perenterol®, Perenterol® forte oder Yomogi® in the last seven days before the start of the study
boolean
C0013216 (UMLS CUI [1])
Systemic antimycotic treatment
Item
Systemic antimycotic treatment
boolean
C3653762 (UMLS CUI [1])
Prior Antibiotic Treatment
Item
Systemic antibiotic treatment within the last 6 weeks
boolean
C0003232 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
Gynaecological Status
Item
No protection against conception, pregnancy, or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Study Participation Status
Item
Simultaneous participation in other clinical trials
boolean
C2348568 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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