Effect of probiotic supplement (L. plantarum strain TENSIA) on healthy volunteers
| ISRCTN | ISRCTN24502121 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24502121 |
| Secondary identifying numbers | 205T-5 |
- 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
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
Scientific
University of Tartu
Faculty of Medicine
Dept of Microbiology
Ravila 19
Tartu
50411
Estonia
| Phone | +372 (0)737 4173 |
|---|---|
| marika.mikelsaar@ut.ee |
Study information
| Study design | Randomized placebo-controlled parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 26/09/2011 |
| Completion date | 14/11/2011 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50, 25 subjects in each arm |
| 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
50411
Estonia
Sponsor information
Industry
Kreutzwaldi 1
51014
Tartu
51014
Estonia
| Phone | +372 (0) 516 4210 |
|---|---|
| ene.tammsaar@tptak.ee | |
| Website | http://www.tptak.ee |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
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.
