ID

23709

Beschrijving

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

Trefwoorden

Versies (1)
  1. 11-07-17 11-07-17 -
Geüploaded op

11 juli 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Antibiotic-associated Diarrhoea NCT01143272 DRKS00000084

Engels

Eligibility Antibiotic-associated Diarrhoea NCT01143272 DRKS00000084

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Patient hospitalized
Beschrijving

Hospitalization

Datatype

boolean

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

Systemic antibiotic treatment

Datatype

boolean

Alias
UMLS CUI [1]
C3540704
Patient contractually capable
Beschrijving

Legal competency

Datatype

boolean

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

Compliance

Datatype

boolean

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

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Beschrijving

Control Group

Datatype

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.
Beschrijving

Hypersensitivity

Datatype

boolean

Alias
UMLS CUI [1]
C0020517
Central venous catheter
Beschrijving

Central venous catheter

Datatype

boolean

Alias
UMLS CUI [1]
C1145640
Immunosuppression
Beschrijving

Immunosuppression

Datatype

boolean

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

Diarrhea

Datatype

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
Beschrijving

Pharmacotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0013216
Systemic antimycotic treatment
Beschrijving

Systemic antimycotic treatment

Datatype

boolean

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

Prior Antibiotic Treatment

Datatype

boolean

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

Gynaecological Status

Datatype

boolean

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

Study Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Antibiotic-associated Diarrhoea NCT01143272 DRKS00000084

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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