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Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea

NCT01143272 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 477

Last updated 2016-07-18

Study results available
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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.

Conditions

  • Antibiotic-associated Diarrhea
  • Clostridium Difficile
  • Diarrhea

Interventions

DRUG

Saccharomyces boulardii

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

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Bernhard Nocht Institute for Tropical Medicine

    lead OTHER_GOV

Principal Investigators

  • Stephan Ehrhardt, MD, MPH · Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01143272 on ClinicalTrials.gov