Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bernhard Nocht Institute for Tropical Medicine
• Collaborator: German Federal Ministry of Education and Research
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

Criteria

Inclusion Criteria:

• adult patient (≥ 18 years)

• patient hospitalized

• patient receives systemic antibiotic treatment

• patient contractually capable

• patient able to follow study procedures

• informed consent of patient

Exclusion Criteria:

• 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