Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/04/2005
Date assigned
24/05/2005
Last edited
23/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marika Mikelsaar

ORCID ID

Contact details

Ravila 19
Tartu
50411
Estonia
+372 7 374170
marika.mikelsaar@ut.ee

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

121/6

Study information

Scientific title

Acronym

Study hypothesis

In 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Healthy subjects

Intervention

Probiotic 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 type

Drug

Phase

Not Specified

Drug names

Probiotic

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

30/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria included the wish to participate, no known health problems, no medical
conditions requiring drug therapy, no other yoghurts or no special diets.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24 adult volunteers (15 men and 9 women)

Participant exclusion criteria

Subjects 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.

Recruitment start date

01/01/2004

Recruitment end date

30/04/2004

Locations

Countries of recruitment

Estonia

Trial participating centre

Ravila 19
Tartu
50411
Estonia

Sponsor information

Organisation

Estonian Science Foundation (Estonia)

Sponsor details

Kohtu 6
Tallinn
10130
Estonia
+372 6 99 6210, +372 6 99 6212
etf@etf.ee

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Estonian Science Foundation ( base funding ref 0418 and 5327)

Alternative name(s)

Estonian Science Foundation, ETF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Estonia

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16080791

Publication citations

  1. Results

    Songisepp E, Kals J, Kullisaar T, Mändar R, Hütt P, Zilmer M, Mikelsaar M, Evaluation of the functional efficacy of an antioxidative probiotic in healthy volunteers., Nutr J, 2005, 4, 22, doi: 10.1186/1475-2891-4-22.

Additional files

Editorial Notes