NCT01143272

Brief Summary

When patients in hospitals receive antibiotics they often develop diarrhoea. The consequences may be grave for the patient. Thus far, no preventive measure is available. The investigators hypothesize that the apathogenic yeast Saccharomyces boulardii, administered in addition to the antibiotic, may prevent episodes of diarrhoea or may lead to less pronounced diarrhoea. To test this hypothesis, the investigators are carrying out a clinical trial in 1520 adult patients in several hospitals.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
477

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

July 18, 2016

Completed
Last Updated

July 18, 2016

Status Verified

June 1, 2016

Enrollment Period

2.3 years

First QC Date

June 11, 2010

Results QC Date

March 17, 2016

Last Update Submit

June 7, 2016

Conditions

Antibiotic-associated DiarrheaClostridium DifficileDiarrhea

Keywords

antibioticassociateddiarrhoeasaccharomyces boulardiiAntibiotic-associated diarrhoea (AAD)Clostridium difficile-associated-diarrhoea (CDAD)

Outcome Measures

Primary Outcomes (1)

  • Total Number of Antibiotic-associated Diarrhea Episodes

    29 months

Secondary Outcomes (6)

  • Total Number of Clostridium Difficile-associated Diarrhea Episodes

    29 months

  • Total Number of Antibiotic-associated Diarrhea Episodes Without Evidence of Clostridium Difficile (Toxins)

    29 months

  • Incidence Density of Antibiotic-associated Diarrhea

    29 months

  • Average Duration of Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea

    29 months

  • Average Number of Bowel Movements in Patients With Antibiotic-associated Diarrhoea and Clostridium Difficile-associated Diarrhea

    29 months

  • +1 more secondary outcomes

Study Arms (2)

Saccharomyces boulardii

ACTIVE COMPARATOR

Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation

Drug: Saccharomyces boulardii

Microcristallin cellulose

PLACEBO COMPARATOR

Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation

Drug: Placebo

Interventions

Saccharomyces boulardiiDRUG

Units: 500 mg per day Route of administration : Oral Use Hard-Capsule

Also known as: Perenterol® Forte
Saccharomyces boulardii
PlaceboDRUG

Placebo

Also known as: Microcristallin cellulose, Matching capsules containing no active ingredients
Microcristallin cellulose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patient (≥ 18 years)
  • patient hospitalized
  • patient receives systemic antibiotic treatment
  • patient contractually capable
  • patient able to follow study procedures
  • informed consent of patient

You may not qualify if:

  • allergy against yeast and/or Perenterol® forte und/oder placebos containing Saccharomyces cerevisiae HANSEN CBS 5926, lactose-monohydrate, magnesium stearate, gelatine, sodium dodecyl sulfate, titan dioxide, microcrystalline cellulose.
  • central venous catheter
  • immunosuppression
  • diarrhoea and/or chronic diarrhoea
  • regular intake of Perenterol®, Perenterol® forte oder Yomogi® in the last seven days before the start of the study
  • systemic antimycotic treatment
  • systemic antibiotic treatment within the last 6 weeks
  • no protection against conception, pregnancy, or lactation
  • simultaneous participation in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Abteilung Innere Medizin, Bundeswehrkrankenhaus Ulm

Ulm, Baden-Würtemberg, 89081, Germany

Location

Klinikum Bremen Ost, Klinik für Innere Medizin

Bremen, City state Bremen, 28325, Germany

Location

I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Agaplesion Diakonieklinikum Hamburg, Klinik für Innere Medizin

Hamburg, Hamburg, 20259, Germany

Location

Bethesda Krankenhaus Bergedorf, Klinik für Innere Medizin

Hamburg, Hamburg, 21029, Germany

Location

Diakoniekrankenhaus Rotenburg (Wümme) gGmbH, Zentrum für Pneumologie

Rotenburg (Wümme), Lower Saxony, 27356, Germany

Location

Klinik und Poliklinik für Innere Medizin, Abteilung für Tropenmedizin und Infektionskrankheiten, Universitätsklinikum Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Knappschaftskrankenhaus Bottrop, Medizinische Klinik

Bottrop, North Rhine-Westphalia, 46242, Germany

Location

Abteilung Akut-Geriatrie, Ev. Krankenhaus Bethanien Iserlohn

Iserlohn, North Rhine-Westphalia, 58644, Germany

Location

Klinikum Vest GmbH, Behandlungszentrum Paracelsus-Klinik Marl

Marl, North Rhine-Westphalia, 45770, Germany

Location

I. Medizinische Klinik und Poliklinik, Johannes-Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Klinikum Saarbrücken

Saarbrücken, Saarland, 66119, Germany

Location

Klinikum St.Georg, Klinik für Infektiologie, Tropenmedizin und Nephrologie

Leipzig, Saxony, 04129, Germany

Location

Abt. Innere Medizin, Krankenhaus Reinbek, St. Adolf -Stift

Reinbek, Schleswig-Holstein, 21465, Germany

Location

Related Publications (1)

  • Ehrhardt S, Guo N, Hinz R, Schoppen S, May J, Reiser M, Schroeder MP, Schmiedel S, Keuchel M, Reisinger EC, Langeheinecke A, de Weerth A, Schuchmann M, Schaberg T, Ligges S, Eveslage M, Hagen RM, Burchard GD, Lohse AW. Saccharomyces boulardii to Prevent Antibiotic-Associated Diarrhea: A Randomized, Double-Masked, Placebo-Controlled Trial. Open Forum Infect Dis. 2016 Jan 29;3(1):ofw011. doi: 10.1093/ofid/ofw011. eCollection 2016 Jan.

    PMID: 26973849DERIVED

Related Links

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Stephan Ehrhardt
Organization
Johns Hopkins Bloomberg School of Public Health
sehrhard@jhsph.edu
410-502-3872

Study Officials

  • Stephan Ehrhardt, MD, MPH

    Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead investigator

Study Record Dates

First Submitted

June 11, 2010

First Posted

June 14, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

July 18, 2016

Results First Posted

July 18, 2016

Record last verified: 2016-06

Locations

DE(14)