Effect of probiotic supplement (L. plantarum strain TENSIA) on healthy volunteers

ISRCTN	ISRCTN24502121
DOI	https://doi.org/10.1186/ISRCTN24502121
Protocol serial number	205T-5
Sponsor	BioCC OÜ
Funder	Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)

Submission date: 09/08/2011
Registration date: 24/08/2011
Last edited: 07/02/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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 BioCC OÜ (Estonia)

When is the study starting and how long is it expected to run for?
September to November 2011

Who is funding the study?
BioCC OÜ (Estonia)

Who is the main contact?
Dr Pirje Hütt
pirje.hutt@ut.ee

Contact information

Prof Marika MIkelsaar
Scientific

University of Tartu
Faculty of Medicine
Dept of Microbiology
Ravila 19
Tartu
50411
Estonia

Phone	+372 (0)737 4173
Email	marika.mikelsaar@ut.ee

Study information

Primary study design	Interventional
Study design	Randomized placebo-controlled parallel trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	TE 7
Study objectives	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(s)	Ethics Review Committee on Human Research of the University of Tartu, 13/06/2011, ref: 205T-5
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	1. Changes in fecal microflora 2. Persistence of ingested probiotic strain for 1 week
Completion date	14/11/2011

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key 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
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	26/09/2011
Date of final enrolment	14/11/2011

Locations

Countries of recruitment

Estonia

Study participating centre

University of Tartu

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/02/2022: The sponsor organisation has been changed from "Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)" to "BioCC OÜ" and the plain English summary has been updated accordingly.
20/09/2016: Publication reference added.