Probiotic Saccharomyces Boulardii for the Prevention of Antibiotic-associated Diarrhoea (SacBo)

Bernhard Nocht Institute for Tropical Medicine

Status and phase: Terminated; Phase 3

Conditions: Diarrhea; Antibiotic-associated Diarrhea; Clostridium Difficile

Treatments: Drug: Saccharomyces boulardii; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01143272

DRKS00000084 (Registry Identifier)

ISRCTN01005546 (Registry Identifier)

2009-017374-20 (EudraCT Number)

BNI-2009-01

Details and patient eligibility

About

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.

Full description

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 carry out 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.

Enrollment: 477 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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477 participants in 2 patient groups, including a placebo group

Saccharomyces boulardii

Active Comparator group

Description:

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

Treatment:

Drug: Saccharomyces boulardii

Microcristallin cellulose

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo