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-11
Study information
Scientific title
Effect of probiotic yoghurt comprising L. plantarum strains TENSIA or INDUCIA on blood indices and intestinal microflora of healthy volunteers: A randomised controlled crossover trial
Acronym
JOG 2
Study hypothesis
The consumption of yoghurt containing probiotic L. plantarum strains has positive impact on intestinal microbiota and blood indices of healthy volunteers.
Ethics approval
The Ethics Review Committee on Human Research of the University of Tartu, 22/02/2010, ref: 190T-11
Study design
Randomised double-blind dietary cross-over intervention study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
GP practices
Trial type
Quality of life
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
The consumption once a day 150g of probiotic yoghurt vs regular yoghurt for 3 weeks. Probiotic yoghurt containing either Lactobacillus plantarum strain TENSIA or INDUCIA (10^9 colony forming units [CFU]/g) After two-week washout period, volunteers are crossed over to another three weeks of probiotic yoghurt or control yoghurt administration.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
1. The health indices of study participants (body mass index, blood pressure) are assessed at the recruitment and after 3 weeks of probiotic treatment.
2. The self-reported questionnaire is applied containing questions on welfare, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), measured once a week during the trial
Fasting blood, faecal samples and morning urine will be taken at the recruitment, after 3 weeks of probiotic treatment, after washout and after placebo treatment.
3. Haematological indices will be measured 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 cell count
3.4. Platelet count
3.5. Plasma glucose
3.6. Albumin
3.7. Total cholesterol (TC)
3.8. Low-density lipoprotein cholesterol (LDL)
3.9. High-density lipoprotein cholesterol (HDL)
3.10. Triglyceride
3.11. High-sensitive C-reactive protein (hs-CRP)
3.12. Interleukin 6 (IL-6)
4. Increased counts of total faecal lactobacilli, measured by Reverse Transcriptase - Polymerase Chain Reaction (RT-PCR)
Secondary outcome measures
Immunological parameters from blood will be measured by routine biochemical analyses in local clinical lab and also by Evidence investigator
1. Significantly increased circulation of polyamines in host, measured by urine gas chromotography
2. Immune stimulation (both cellular and humoral immunity)
Overall trial start date
29/03/2010
Overall trial end date
24/05/2010
Reason abandoned (if study stopped)
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
120 volunteers recruited from GP clinics (60 per intervention group, subdivided to 30 test subjects & 30 controls)
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
29/03/2010
Recruitment end date
24/05/2010
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25524863