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 measure
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 (if study stopped)
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
Trusts, charities, foundations (both public and private)
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
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16080791
Publication citations
-
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.