ID

13431

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. 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.

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1. 2/8/16 2/8/16 -
2. 2/11/16 2/11/16 -

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February 11, 2016

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