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Data set

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

Example 

Data category 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) . . .

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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