ID

13430

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. 2/8/16 2/8/16 -
  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 Readmission DRKS00000084 NCT01143272

English

SacBo PZ: Case Report Form Hospitalization Readmission NCT01143272

1 forms  
Readmission
Description

Readmission

When was the patient readmitted to the hospital?
Description

Hospital readmission date

Data type

date

Alias
UMLS CUI [1,1]
C0600290
UMLS CUI [1,2]
C0011008
Was the patient readmitted as an out-patient or as an in-patient?
Description

Readmission/return assessment. Please enter the medication obligatory for documentation in the "patient diary after discharge/transferal" AND in the data base. Please enter all other pages in the data base (except for patient diary) as well.

Data type

integer

Alias
UMLS CUI [1]
C3844773
What was the reason for the return/readmission to the hospital?
Description

Reason for return/readmission

Data type

integer

Alias
UMLS CUI [1]
C3844773
What phase of the study is the patient currently in?
Description

Study phase

Data type

integer

Alias
UMLS CUI [1]
C2348568
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Similar models

SacBo PZ: Case Report Form Hospitalization Readmission NCT01143272

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Readmission
Hospital readmission
Item
When was the patient readmitted to the hospital?
date
C0600290 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Was the patient readmitted as an out-patient or as an in-patient?
integer
C3844773 (UMLS CUI [1])
readmission/return assessment
Code List
Was the patient readmitted as an out-patient or as an in-patient?
CL Item
out-patient (1)
CL Item
in-patient (2)
Item
What was the reason for the return/readmission to the hospital?
integer
C3844773 (UMLS CUI [1])
Reason for return/readmission
Code List
What was the reason for the return/readmission to the hospital?
CL Item
Diarrhea/AAD/CDAD (1)
CL Item
Aggravation of underlying disease (2)
CL Item
Known and listed side effect of the antibiotic used (3)
CL Item
Adverse event (4)
CL Item
other reason (5)
Item
What phase of the study is the patient currently in?
integer
C2348568 (UMLS CUI [1])
study section
Code List
What phase of the study is the patient currently in?
CL Item
Treatment 1 (1)
CL Item
Treatment 2 (2)
CL Item
Follow Up (3)
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