Contact information
Type
Scientific
Primary contact
Prof Marika Mikelsaar
ORCID ID
Contact details
Ravila str 19
Tartu
50411
Estonia
marika.mikelsaar@ut.ee
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
190T-10 from 22.02.2010
Study information
Scientific title
Effect of different doses of L. planatrum TENSIA containing probiotic cheese on blood indices and intestinal microflora of healthy adult volunteers: An open label, interventional study
Acronym
TE 5
Study hypothesis
1. The consumption of a probiotic Lactobacillus plantarum strain containing cheese in daily (high) dose of 100g (probiotic dose being 10^11 CFU)
1.1. is safe: no negative gastrointestinal effect, no elevated total cholesterol and no negative shifts in cholesterol fractions
1.2. affects positively the functions of the cardio-vascular system of human body.
2. The consumption of a probiotic Lactobacillus plantarum strain containing cheese in daily (low) dose of 100g (probiotic dose being 10^5 Colony Forming Units [CFU]) has positive impact on blood indices of healthy volunteers.
Ethics approval
The Ethics Review Committee on Human Research of the University of Tartu approved on the 22nd of February 2010 (ref: 190T-10)
Study design
Open interventional dose safety study
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 contact Dr Pirje Hütt [pirje.hutt@ut.ee] to request a patient information sheet (in Estonian)
Condition
blood indices and intestinal microflora
Intervention
Probiotic cheese consumption
Group I of volunteers 100 g probiotic cheese once a day for 3 weeks in a daily dose of probitoic being 10^5 CFU
Group II of volunteers 100 g probiotic cheese once a day for 3 weeks in a daily dose of probitoic being 10^11 CFU
Blood, urine and faecal samples are collected at the recruitment, and after 3 weeks of probiotic treatment
Samples of fasting blood, fecal and urine samples will be collected at recruitment and at the end of the trial after administration of the L. plantarum TENSIA comprising cheese.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. The health indices of study participants are assessed at the recruitment and after 3 weeks of probiotic treatment.
1.1. Height
1.2. Weight
1.3. Body mass index (BMI)
1.4. Blood pressure
2. The self-reported questionnaire is applied containing questions on welfare, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), is filled once a week during the trial
3. Haematological indices will be determined at the recruitment and after 3 weeks of probiotic treatment. by standard laboratory methods using certified assays in the local clinical laboratory (United Laboratories of Tartu University Clinics, Estonia).
3.1. Haemoglobin
3.2. White blood cell count
3.3. Red blood cells count
3.4. Platelet count
4. Routine biochemical indices will be determined at the recruitment and after 3 weeks of probiotic treatment
4.1. Albumin
4.2. Ferritine
4.3. Plasma glucose
4.4. High-sensitive CRP (hs-CRP)
4.5. Total cholesterol
4.6. LDL-cholesterol (LDL)
4.7. HDL-cholesterol (HDL)
4.8. Triglycerides
4.9. Serum creatinine
4.10. Alanine transaminase (ALAT)
4.11. Aspartate transaminase (ASAT)
4.12. Immunoglobulin IgE levels
5. Safety of high doses of TENSIA
Secondary outcome measures
Positive impact on human health
Overall trial start date
10/05/2010
Overall trial end date
14/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Wish to participate in the study
2. Aged 18 years and over, both sexes
3. Healthy (i.e. no known health problems and no medical conditions that require drug therapy)
4. Signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 recruited from GP clinics, divided into in two groups
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
10/05/2010
Recruitment end date
14/06/2010
Locations
Countries of recruitment
Estonia
Trial participating centre
Ravila str 19
Tartu
50411
Estonia
Sponsor information
Organisation
Bio-Competence Centre of Healthy Dairy Products Ltd (Estonia)
Sponsor details
Kreutzwaldi str 1
Tartu
51014
Estonia
+372 (0)731 3411
ene.tammsaar@tptak.ee
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Bio-Competence Centre of Healthy Dairy Products Ltd (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