Data set

Item 2b: All items from the World Health Organization Trial Registration Data Set.

Example 

[table nl=”~~” div style=”float:left” class=”table table-bordered” tablesorter=”0″ table delimiter=”|”]
Data category[attr width=”175″]|Information32
Primary registry and trial identifying number|ClinicalTrials.gov~~NCT01143272
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 . . .
Study type|Interventional~~Allocation: randomized~~Intervention model: parallel assignment~~Masking: double blind (subject, caregiver, investigator, outcomes assessor)~~Primary purpose: prevention~~Phase III
Date of first enrolment|June 2010
Target sample size|1520
Recruitment status|Recruiting
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) . . .[/table]

Explanation

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

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