ID
13431
Beschrijving
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. Please note: 1) At first hospitalization please enter the antibiotic initially used in the first line! 2) Please enter the medication in chronological order! 3) Obligatory documentation starts with the date the (re-) hospitalization begins! If there is preexisting medication the starting date is determined as follows: a) First hospitalization = Date of first dose of antibiotic! b) Rehospitalization = Date of Rehospitalization! 4) Documentation of the last dose of any of the medication subject for documentation is only necessary until the regular end of the study.
Trefwoorden
Versies (2)
- 08-02-16 08-02-16 -
- 11-02-16 11-02-16 -
Geüploaded op
11 februari 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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SacBo PZ: Case Report Form Hospitalization Medication subject to documentation DRKS00000084 NCT01143272
SacBo PZ: Case Report Form Hospitalization Medication subject to documentation NCT01143272
Beschrijving
Further medication subject to documentation
Beschrijving
Number of medication
Datatype
text
Beschrijving
Medication
Datatype
integer
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
First dose
Datatype
date
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0205435
- UMLS CUI [1,3]
- C0011008
Beschrijving
Last dose
Datatype
date
Alias
- UMLS CUI [1]
- C1762893
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SacBo PZ: Case Report Form Hospitalization Medication subject to documentation NCT01143272
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C0205435 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0205435 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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