Trial document




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  DRKS00000084

Trial Description

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Title

Probiotic Saccharomyces boulardii for the prevention of antibiotic-associated diarrhoea. Randomised, double-blind, placebo-controlled trial

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Trial Acronym

SacBo

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URL of the Trial

http://www.clinicaltrial-sacbo.de

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Brief Summary in Lay Language

During antibiotic treatment in hospital the occurance of diarrhoea in patients is common. This diarrhoea may be severe and life-threatening. To date, no measures of proven efficacy to prevent the occurence of this diarrhoea exist. The apathogenic yeast, Saccharomyces boulardii, has the potential to prevent this diarrhoea. A clinical trial shall prove the hypothesis that Saccharomyces boulardii prevents diarrhoea in patients when administered alongside an antibiotic.

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Brief Summary in Scientific Language

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 designed 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.

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Organizational Data

  •   DRKS00000084
  •   2010/04/21
  •   2010/06/07
  •   yes
  •   Approved
  •   PVN 3440, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   U1111-1114-7443 
  •   2009-017374-20 
  •   ISRCTN01005546  ((International Standard Randomised Controlled Trial Number Register))
  •   4036133 
  •   BNI-2009-01  (Bernhard-Nocht-Institut für Tropenmedizin)
  •   NCT01143272  ((Clinical.Trials.gov))
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Health Condition or Problem studied

  •   antibiotic-associated diarrhoea
  •   A04.7 -  Enterocolitis due to Clostridium difficile
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Interventions/Observational Groups

  •   bid 250 mg Perenterol forte orally when beginning antibiotic treatment until 1 week after end of antibiotic treatment (duration variable).
  •   bid placebo when beginning antibiotic treatment until 1 week after end of antibiotic treatment (duration variable).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   [---]*
  •   Placebo
  •   Prevention
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

Cumulative incidence of antibiotic-associated diarrhoea (AAD)

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Secondary Outcome

Cumulative incidence of Clostridium difficile-associated diarrhoea (CDAD) || Cumulative incidence of AAD without evidence of an CDAD || Cumulative incidence of a CDAD within all AAD patients || Occurance of an AAD in dependence from initial number of leucocytes and CRP || Occurance of a CDAD in dependence from initial number of leucocytes and CRP || Incidence density of an AAD or rather CDAD || Average duration of an AAD or rather CDAD || Average stool frequency at an AAD or rather CDAD || Cumulative incidence of stopping or changing the initially applied anibiotic therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/07/09
  •   1520
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Adult, hospitalized patients receiving systemic antibiotic treatment; patient is competent to contract; patient is physically and psychologically able to follow the trial process; written informed consent.

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Exclusion Criteria

Allergy against Saccharomyces boulardii;
Central venous catheter;
Immunosuppression;
Chronic diarrhoea;
Regular intake of Saccharomyces boulardii before beginning of the study;
Systemic antimycotic treatment;
Systemic antibiotic treatment within the last 6 weeks;
Missing contraception (failure rate < 1%/year) for the duration of the study at women in childbearing age, pregnancy or breastfeeding women;

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Addresses

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    • Bernhard-Nocht-Institut für Tropenmedizin
    • Bernhard-Nocht-Str. 74
    • 20359  Hamburg
    • Germany
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    • Bernhard-Nocht-Institut für Tropenmedizin
    • Mr.  Dr. med.  Stephan  Ehrhardt 
    • Bernhard-Nocht-Str. 74
    • 20359  Hamburg
    • Germany
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    • Bernhard-Nocht-Institut für Tropenmedizin
    • Ms.  Rebecca  Hinz 
    • Bernhard-Nocht-Str. 74
    • 20359  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • BMBF
    • BMBF Programm "Klinische Studien" 
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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    •   0228-9957-0
    •   0228-9957-83601
    •   [---]*
    •   http://www.bmbf.de
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Status

  •   Recruiting stopped after recruiting started
  •   2012/11/01
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.