Saccharomyces boulardii to prevent antibiotic-associated diarrhea: A randomized, double-masked, placebo-controlled trial

for the SacBo Study Groupa

Research output: Contribution to journalArticle

Abstract

Background. Antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) are common complications of antibiotic use. Data on the efficacy of probiotics to prevent AAD and CDAD are unclear. We aimed to evaluate the efficacy of Saccharomyces boulardii to prevent AAD and CDAD in hospitalized adult patients. Methods. We conducted a multicenter, phase III, double-masked, randomized, placebo-controlled trial in hospitalized patients who received systemic antibiotic treatment in 15 hospitals in Germany between July 2010 and October 2012. Participants received Perenterol forte 250 mg capsules or matching placebo twice per day within 24 hours of initiating antibiotic treatment, continued treatment for 7 days after antibiotic discontinuation, and were then observed for 6 weeks. Results. Two thousand four hundred forty-four patients were screened. The trial was stopped early for futility after inclusion of 477. participants. Two hundred forty-six patients aged 60.1 ± 16.5 years and 231 patients aged 56.5 ± 17.8 were randomized to the S boulardii group and the placebo group, respectively, with 21 and 19 AADs in the respective groups (P =87). The hazard ratio of AAD in the S boulardii group compared with the placebo group was 1.02 (95% confidence interval,.55-1.90; P =94). Clostridium difficile-associated diarrhea occurred in 0.8% of participants (4 of 477). Nine serious adverse events were recorded in the S boulardii group, and 3 serious adverse events were recorded in the placebo group. None were related to study participation. Conclusions. We found no evidence for an effect of S boulardii in preventing AAD or CDAD in a population of hospitalized patients without particular risk factors apart from systemic antibiotic treatment.

Original languageEnglish (US)
Article numberofw011
JournalOpen Forum Infectious Diseases
Volume3
Issue number1
DOIs
StatePublished - Jan 1 2016

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Diarrhea
Placebos
Anti-Bacterial Agents
Clostridium difficile
Saccharomyces boulardii
Medical Futility
Probiotics
Therapeutics
Capsules
Germany
Randomized Controlled Trials
Confidence Intervals
Population

Keywords

  • Antibiotic-associated diarrhea
  • Clostridium difficile-associated diarrhea
  • Probiotic
  • Randomized controlled trial
  • Saccharomyces boulardii

ASJC Scopus subject areas

  • Oncology
  • Clinical Neurology

Cite this

Saccharomyces boulardii to prevent antibiotic-associated diarrhea : A randomized, double-masked, placebo-controlled trial. / for the SacBo Study Groupa.

In: Open Forum Infectious Diseases, Vol. 3, No. 1, ofw011, 01.01.2016.

Research output: Contribution to journalArticle

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title = "Saccharomyces boulardii to prevent antibiotic-associated diarrhea: A randomized, double-masked, placebo-controlled trial",
abstract = "Background. Antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) are common complications of antibiotic use. Data on the efficacy of probiotics to prevent AAD and CDAD are unclear. We aimed to evaluate the efficacy of Saccharomyces boulardii to prevent AAD and CDAD in hospitalized adult patients. Methods. We conducted a multicenter, phase III, double-masked, randomized, placebo-controlled trial in hospitalized patients who received systemic antibiotic treatment in 15 hospitals in Germany between July 2010 and October 2012. Participants received Perenterol forte 250 mg capsules or matching placebo twice per day within 24 hours of initiating antibiotic treatment, continued treatment for 7 days after antibiotic discontinuation, and were then observed for 6 weeks. Results. Two thousand four hundred forty-four patients were screened. The trial was stopped early for futility after inclusion of 477. participants. Two hundred forty-six patients aged 60.1 ± 16.5 years and 231 patients aged 56.5 ± 17.8 were randomized to the S boulardii group and the placebo group, respectively, with 21 and 19 AADs in the respective groups (P =87). The hazard ratio of AAD in the S boulardii group compared with the placebo group was 1.02 (95{\%} confidence interval,.55-1.90; P =94). Clostridium difficile-associated diarrhea occurred in 0.8{\%} of participants (4 of 477). Nine serious adverse events were recorded in the S boulardii group, and 3 serious adverse events were recorded in the placebo group. None were related to study participation. Conclusions. We found no evidence for an effect of S boulardii in preventing AAD or CDAD in a population of hospitalized patients without particular risk factors apart from systemic antibiotic treatment.",
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author = "{for the SacBo Study Groupa} and Stephan Ehrhardt and Nan Guo and Rebecca Hinz and Stefanie Schoppen and J{\"u}rgen May and Markus Reiser and Schroeder, {Maximilian Philipp} and Stefan Schmiedel and Martin Keuchel and Reisinger, {Emil C.} and Andreas Langeheinecke and {de Weerth}, Andreas and Marcus Schuchmann and Tom Schaberg and Sandra Ligges and Maria Eveslage and Hagen, {Ralf M.} and Burchard, {Gerd D.} and Lohse, {Ansgar W.} and Ruf, {Bernhard H.} and Rainer Porschen and Guido Trenn and Trude Butterfa{\ss}-Bahloul and Gudrun Wuerthwein and Marc Urban and Frank Oeder and Andreas Runge and Esther Klauss and Nina Hansen-Rosenblatt and Tobias Werner and Kornelius Schulze and Benno Kreuels and Guido Sch{\"a}fer and Peter H{\"u}bener and Annette Hennigs and Claudia Beisel and Dorothee Fischer-Br{\"u}gge and Katharina Zimmermann-Fraedrich and Claudia R{\"o}der and Nadine Grigo and Armin Riecke and Helmut Schreckenbauer and Christoph Hemmer and Sebastian Klammt and Hilte Geerdes-Fenge and Silvius Frimmel and Kittner, {Jens M.} and Rey, {Johannes W.} and Schattenberg, {Joern M.} and Florian Thieringer",
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TY - JOUR

T1 - Saccharomyces boulardii to prevent antibiotic-associated diarrhea

T2 - A randomized, double-masked, placebo-controlled trial

AU - for the SacBo Study Groupa

AU - Ehrhardt, Stephan

AU - Guo, Nan

AU - Hinz, Rebecca

AU - Schoppen, Stefanie

AU - May, Jürgen

AU - Reiser, Markus

AU - Schroeder, Maximilian Philipp

AU - Schmiedel, Stefan

AU - Keuchel, Martin

AU - Reisinger, Emil C.

AU - Langeheinecke, Andreas

AU - de Weerth, Andreas

AU - Schuchmann, Marcus

AU - Schaberg, Tom

AU - Ligges, Sandra

AU - Eveslage, Maria

AU - Hagen, Ralf M.

AU - Burchard, Gerd D.

AU - Lohse, Ansgar W.

AU - Ruf, Bernhard H.

AU - Porschen, Rainer

AU - Trenn, Guido

AU - Butterfaß-Bahloul, Trude

AU - Wuerthwein, Gudrun

AU - Urban, Marc

AU - Oeder, Frank

AU - Runge, Andreas

AU - Klauss, Esther

AU - Hansen-Rosenblatt, Nina

AU - Werner, Tobias

AU - Schulze, Kornelius

AU - Kreuels, Benno

AU - Schäfer, Guido

AU - Hübener, Peter

AU - Hennigs, Annette

AU - Beisel, Claudia

AU - Fischer-Brügge, Dorothee

AU - Zimmermann-Fraedrich, Katharina

AU - Röder, Claudia

AU - Grigo, Nadine

AU - Riecke, Armin

AU - Schreckenbauer, Helmut

AU - Hemmer, Christoph

AU - Klammt, Sebastian

AU - Geerdes-Fenge, Hilte

AU - Frimmel, Silvius

AU - Kittner, Jens M.

AU - Rey, Johannes W.

AU - Schattenberg, Joern M.

AU - Thieringer, Florian

PY - 2016/1/1

Y1 - 2016/1/1

N2 - Background. Antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) are common complications of antibiotic use. Data on the efficacy of probiotics to prevent AAD and CDAD are unclear. We aimed to evaluate the efficacy of Saccharomyces boulardii to prevent AAD and CDAD in hospitalized adult patients. Methods. We conducted a multicenter, phase III, double-masked, randomized, placebo-controlled trial in hospitalized patients who received systemic antibiotic treatment in 15 hospitals in Germany between July 2010 and October 2012. Participants received Perenterol forte 250 mg capsules or matching placebo twice per day within 24 hours of initiating antibiotic treatment, continued treatment for 7 days after antibiotic discontinuation, and were then observed for 6 weeks. Results. Two thousand four hundred forty-four patients were screened. The trial was stopped early for futility after inclusion of 477. participants. Two hundred forty-six patients aged 60.1 ± 16.5 years and 231 patients aged 56.5 ± 17.8 were randomized to the S boulardii group and the placebo group, respectively, with 21 and 19 AADs in the respective groups (P =87). The hazard ratio of AAD in the S boulardii group compared with the placebo group was 1.02 (95% confidence interval,.55-1.90; P =94). Clostridium difficile-associated diarrhea occurred in 0.8% of participants (4 of 477). Nine serious adverse events were recorded in the S boulardii group, and 3 serious adverse events were recorded in the placebo group. None were related to study participation. Conclusions. We found no evidence for an effect of S boulardii in preventing AAD or CDAD in a population of hospitalized patients without particular risk factors apart from systemic antibiotic treatment.

AB - Background. Antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) are common complications of antibiotic use. Data on the efficacy of probiotics to prevent AAD and CDAD are unclear. We aimed to evaluate the efficacy of Saccharomyces boulardii to prevent AAD and CDAD in hospitalized adult patients. Methods. We conducted a multicenter, phase III, double-masked, randomized, placebo-controlled trial in hospitalized patients who received systemic antibiotic treatment in 15 hospitals in Germany between July 2010 and October 2012. Participants received Perenterol forte 250 mg capsules or matching placebo twice per day within 24 hours of initiating antibiotic treatment, continued treatment for 7 days after antibiotic discontinuation, and were then observed for 6 weeks. Results. Two thousand four hundred forty-four patients were screened. The trial was stopped early for futility after inclusion of 477. participants. Two hundred forty-six patients aged 60.1 ± 16.5 years and 231 patients aged 56.5 ± 17.8 were randomized to the S boulardii group and the placebo group, respectively, with 21 and 19 AADs in the respective groups (P =87). The hazard ratio of AAD in the S boulardii group compared with the placebo group was 1.02 (95% confidence interval,.55-1.90; P =94). Clostridium difficile-associated diarrhea occurred in 0.8% of participants (4 of 477). Nine serious adverse events were recorded in the S boulardii group, and 3 serious adverse events were recorded in the placebo group. None were related to study participation. Conclusions. We found no evidence for an effect of S boulardii in preventing AAD or CDAD in a population of hospitalized patients without particular risk factors apart from systemic antibiotic treatment.

KW - Antibiotic-associated diarrhea

KW - Clostridium difficile-associated diarrhea

KW - Probiotic

KW - Randomized controlled trial

KW - Saccharomyces boulardii

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U2 - 10.1093/ofid/ofw011

DO - 10.1093/ofid/ofw011

M3 - Article

C2 - 26973849

AN - SCOPUS:85000580131

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