Plain English Summary
Background and study aims
Probiotics are live bacteria and yeasts promoted as having various health benefits. Probiotic products include food products such as yoghurt and dietary supplements in capsule, powder or liquid form. Centuries-long use of lactic acid bacteria in the food industry has proven their safety. Nevertheless, it is important to test the safety of each potential probiotic. The aim of this study is to assess the safety of a probiotic food supplement, the survival of the probiotic bacteria in the gut, and its effect on the gut bacteria.
Who can participate?
Healthy volunteers aged 18 and over
What does the study involve?
Participants are randomly allocated to take either the probiotic supplement or a placebo (dummy supplement). They are asked to fill in a questionnaire assessing any digestive symptoms (stomach pain, flatulence, bloating, and stool frequency) once a week and to provide blood, urine and fecal samples to test the effect of the probiotic supplement on the human body.
What are the possible benefits and risks of participating?
All participants receive an assessment of their health status and if necessary, a consultation with a nutritionist. The study causes minimal inconvenience to participants. As blood samples are taken by an experienced nurse, the procedure is safe. However, there may be bruising and discomfort at the site of the blood test as with any blood test. The amounts of blood we are taking are small enough that they should not make participants feel fatigue or cause anemia. There may be local red reactions at the site of the injections.
Where is the study run from?
Centre for Clinical and Physiological Research of the Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)
When is the study starting and how long is it expected to run for?
September to November 2011
Who is funding the study?
Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)
Who is the main contact?
Dr Pirje Hütt
pirje.hutt@ut.ee
Trial website
Contact information
Type
Scientific
Primary contact
Prof Marika MIkelsaar
ORCID ID
Contact details
University of Tartu
Faculty of Medicine
Dept of Microbiology
Ravila 19
Tartu
50411
Estonia
+372 (0)737 4173
marika.mikelsaar@ut.ee
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
205T-5
Study information
Scientific title
Effect of a food supplement containing the probiotic strain of Lactobacillus plantarum TENSIA DSM 21380 on blood indices and intestinal microflora of healthy volunteers: a randomized placebo-controlled parallel trial
Acronym
TE 7
Study hypothesis
The consumption of probiotic dietary supplement containing L. plantarum strain TENSIA is safe:
1. No adverse gastrointestinal effects (i.e. no abdominal discomfort like abdominal pain, flatulence or bloating,
2. No negative shifts in values of systemic inflammation markers
3. No allergic sensibilisation
4. No harm to essential organs
5. No unwanted changes in the glucose content in blood serum or in lipid metabolism
Ethics approval
Ethics Review Committee on Human Research of the University of Tartu, 13/06/2011, ref: 205T-5
Study design
Randomized placebo-controlled parallel trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Improving intestinal flora
Intervention
Participants randomised to active or placebo group will be required during 3 weeks:
1. Active intervention: probiotic supplement containing Lactobacillus plantarum strain TENSIA (daily dose: 3x10/10 colony forming units [CFU])
2. Placebo group: maltodextrin 100 mg
Intervention type
Supplement
Phase
Phase I
Drug names
L. plantarum strain TENSIA supplement
Primary outcome measures
1. Adverse gastrointestinal effects
2. Negative shifts in values of systemic inflammation markers
3. Changes in lipid metabolism
4. Changes in key immunological parameters and markers of oxidative stress
5. Reduction of blood pressure
Measured pre intervention, at the end of the intervention and also 1 week post intervention
Secondary outcome measures
1. Changes in fecal microflora
2. Persistence of ingested probiotic strain for 1 week
Overall trial start date
26/09/2011
Overall trial end date
14/11/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Wish to participate in the study
2. Aged 18 years and over
3. Healthy (i.e., no known health problems and no medical conditions that require drug therapy)
4. Signed informed consent
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
50, 25 subjects in each arm
Participant exclusion criteria
1. History of any gastrointestinal disease
2. Use of any antimicrobial drug within last month
3. Use of any regular concomitant medication, including medical preparations
4. Food allergy
5. Pregnancy or breastfeeding
Recruitment start date
26/09/2011
Recruitment end date
14/11/2011
Locations
Countries of recruitment
Estonia
Trial participating centre
University of Tartu
Tartu
50411
Estonia
Sponsor information
Organisation
Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)
Sponsor details
Kreutzwaldi 1
51014
Tartu
51014
Estonia
+372 (0) 516 4210
ene.tammsaar@tptak.ee
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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