Item 2b: All items from the World Health Organization Trial Registration Data Set.
|Primary registry and trial identifying number||ClinicalTrials.gov
|Date of registration in primary registry||11 June, 2010|
|Secondary identifying numbers||BNI-2009-01, 2009-017374-20, ISRCTN01005546, DRKS00000084|
|Source(s) of monetary or material support||Bernhard Nocht Institute for Tropical Medicine|
|Primary sponsor||Bernhard Nocht Institute for Tropical Medicine|
|Secondary sponsor(s)||German Federal Ministry of Education and Research|
|Contact for public queries||SE, MD, MPH [phone number] [email address]|
|Contact for scientific queries||SE, MD, MPH
Bernhard Nocht Institute for Tropical Medicine Hamburg, Germany
|Public title||Probiotic Saccharomyces boulardii for the prevention of antibiotic associated diarrhoea (SacBo)|
|Scientific title||Saccharomyces boulardii for the prevention of antibiotic associated diarrhoea—randomised, double blind, placebo controlled trial|
|Countries of recruitment||Germany|
|Health condition(s) or problem(s) studied||Antibiotic treatment, Clostridium difficile, diarrhoea|
|Intervention(s)||Active comparator: S boulardii (500 mg S boulardii per day)
Placebo comparator: microcristallin cellulose (matching capsules containing no active ingredients)
|Key inclusion and exclusion criteria||Ages eligible for study: ≥18 years
Sexes eligible for study: both
Accepts healthy volunteers: no
Inclusion criteria: adult patient (≥ 18 years), patient hospitalised . . .
Exclusion criteria: allergy against yeast and/or Perenterol forte and/or placebos containing S cerevisiae HANSEN CBS 5926, lactose monohydrate, magnesium stearate, gelatine, sodium dodecyl sulfate, titan dioxide, microcrystalline cellulose . . .
Intervention model: parallel assignment
Masking: double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose: prevention
|Date of first enrolment||June 2010|
|Target sample size||1520|
|Primary outcome(s)||Cumulative incidence of any antibiotic associated diarrhoea (time frame: 2 years; not designated as safety issue)|
|Key secondary outcomes||Cumulative incidence of C difficile associated diarrhoea (time frame: 2 years; not designated as safety issue) . . .|
In addition to a trial registration number, the World Health Organization (WHO) recommends a minimum standard list of items to be included in a trial registry in order for a trial to be considered fully registered (http://www.who.int/ictrp/network/trds/en/index.html). These standards are supported by ICMJE, other journal editors, and jurisdictional legislation.29-31 We recommend that the WHO Trial Registration Data Set be included in the protocol to serve as a brief structured summary of the trial. Its inclusion in the protocol can also signal updates for the registry when associated protocol sections are amended – thereby promoting consistency between information in the protocol and registry.
|2a: Trial registration – Registry||3: Protocol version|