ID

13424

Descrição

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.

Palavras-chave

  1. 05/02/2016 05/02/2016 -
  2. 11/02/2016 11/02/2016 -
Transferido a

11 de fevereiro de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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SacBo TI: Case Report Form End Of Study Study Discontinuation DRKS00000084 NCT01143272

SacBo TI: Case Report Form End Of Study Study Discontinuation NCT01143272

End of study / study discontinuation
Descrição

End of study / study discontinuation

Did the study end regularly?
Descrição

End of Study

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0444496
Did the patient leave the study early?
Descrição

Early study termination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2718058
What date was the end of study or the study termination
Descrição

Date of end of study or of early study termination

Tipo de dados

date

Alias
UMLS CUI [1]
C0011008
If study discontinuation
Descrição

If study discontinuation

Did the patient revoke written consent?
Descrição

revocation of written consent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0680801
Was the patient lost to follow up?
Descrição

Lost to follow up

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1302313
Did the patient become retrospectively ineligible for this study and if so what criterion was the reason for becoming ineligible?
Descrição

retrospectively ineligible

Tipo de dados

integer

Alias
UMLS CUI [1]
C1512714
Was there any other reason for early study termination?
Descrição

any other reason

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2718058

Similar models

SacBo TI: Case Report Form End Of Study Study Discontinuation NCT01143272

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
End of study / study discontinuation
End of Study
Item
Did the study end regularly?
boolean
C0444496 (UMLS CUI [1])
Early study termination
Item
Did the patient leave the study early?
boolean
C2718058 (UMLS CUI [1])
Date of end of study or of early study termination
Item
What date was the end of study or the study termination
date
C0011008 (UMLS CUI [1])
Item Group
If study discontinuation
revocation of written consent
Item
Did the patient revoke written consent?
boolean
C0021430 (UMLS CUI [1,1])
C0680801 (UMLS CUI [1,2])
Lost to follow up
Item
Was the patient lost to follow up?
boolean
C1302313 (UMLS CUI [1])
Item
Did the patient become retrospectively ineligible for this study and if so what criterion was the reason for becoming ineligible?
integer
C1512714 (UMLS CUI [1])
Code List
Did the patient become retrospectively ineligible for this study and if so what criterion was the reason for becoming ineligible?
CL Item
Adult (Inclusion1 )
CL Item
Patient physically and mentally fit (Inclusion5 )
CL Item
Patient hospitalized in study hospital (Inclusion2 )
CL Item
systemic antiobiotic treatment planned (>= 3 days) (Inclusion3 )
CL Item
Patient contractually capable (Inclusion4 )
CL Item
For women of child-bearing age: contraception (Inclusion6 )
CL Item
Informed consent obtained (Inclusion7 )
CL Item
Hypersensitivity to yeast and/or perenterol (Exclusion1 )
CL Item
Central venous catheterization (Exclusion2 )
CL Item
Immunosuppression (Exclusion3 )
CL Item
Currently having diarrhea and/or frequent diarrhea (Exclusion4 )
CL Item
Frequent use of perenterol or yomogi (7 days before start of study) (Exclusion5 )
CL Item
systemic antifungal treatment (Exclusion6 )
CL Item
systemic antibiotic treatment (6 weeks before start of study) (Exclusion7 )
CL Item
for women: pregnancy (Exclusion8 )
CL Item
for women: lactation (Exclusion9 )
CL Item
currently participating in another trial (Exclusion10 )
any other reason
Item
Was there any other reason for early study termination?
boolean
C2718058 (UMLS CUI [1])

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