Effect of probiotic yoghurt on blood indices and intestinal microflora of healthy volunteers

ISRCTN	ISRCTN79645828
DOI	https://doi.org/10.1186/ISRCTN79645828
Protocol serial number	190T-11
Sponsor	Bio-Competence Centre of Healthy Dairy Products Ltd (Estonia)
Funder	Bio-Competence Centre of Healthy Dairy Products Ltd (Estonia)

Submission date: 10/03/2010
Registration date: 18/03/2010
Last edited: 16/12/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marika Mikelsaar
Scientific

Ravila str 19
Tartu
50411
Estonia

Email	marika.mikelsaar@ut.ee

Study information

Primary study design	Interventional
Study design	Randomised double-blind dietary cross-over intervention study
Secondary study design	Randomised cross over trial
Study type	Participant information sheet
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
Study acronym	JOG 2
Study objectives	The consumption of yoghurt containing probiotic L. plantarum strains has positive impact on intestinal microbiota and blood indices of healthy volunteers.
Ethics approval(s)	The Ethics Review Committee on Human Research of the University of Tartu, 22/02/2010, ref: 190T-11
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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)
Completion date	24/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	29/03/2010
Date of final enrolment	24/05/2010

Locations

Countries of recruitment

Estonia

Study participating centre

Ravila str 19

Tartu
50411
Estonia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2015		Yes	No
Results article		01/05/2022	16/12/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/12/2022: Publication reference added.
08/03/2016: Publication reference added.