ISRCTN ISRCTN53164826
DOI https://doi.org/10.1186/ISRCTN53164826
Secondary identifying numbers 121/6
Submission date
18/04/2005
Registration date
24/05/2005
Last edited
23/05/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marika Mikelsaar
Scientific

Ravila 19
Tartu
50411
Estonia

Phone +372 7 374170
Email marika.mikelsaar@ut.ee

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesIn non-diseased host the probiotic health claims could be assessed by improvement of some measurable laboratory indices of well-established physiological functions of host, e.g. markers of antioxidative defense system.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHealthy subjects
InterventionProbiotic capsule versus placebo capsule.
1. The study group members (8 males and 4 females) took three probiotic containing capsules (8.4 log colony forming unit [CFU] per capsule) two times daily (daily dose 9.2 log CFU) for three weeks.
2. The placebo group (7 males and 5 females) received identical capsules without the probiotic strain.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Probiotic
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2004
Completion date30/04/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants24 adult volunteers (15 men and 9 women)
Key inclusion criteriaInclusion criteria included the wish to participate, no known health problems, no medical
conditions requiring drug therapy, no other yoghurts or no special diets.
Key exclusion criteriaSubjects with a history of gastrointestinal tract (GIT) disease, food allergy and acute infection, use of any antimicrobial agent within the last month or use of any regular concomitant medication were excluded.
Date of first enrolment01/01/2004
Date of final enrolment30/04/2004

Locations

Countries of recruitment

  • Estonia

Study participating centre

Ravila 19
Tartu
50411
Estonia

Sponsor information

Estonian Science Foundation (Estonia)
Government

Kohtu 6
Tallinn
10130
Estonia

Phone +372 6 99 6210, +372 6 99 6212
Email etf@etf.ee

Funders

Funder type

Government

Estonian Science Foundation ( base funding ref 0418 and 5327)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Estonian Science Foundation, ETF
Location
Estonia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 04/08/2005 Yes No