Condition category
Digestive System
Date applied
09/08/2011
Date assigned
24/08/2011
Last edited
20/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 the Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)

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

Who is funding the study?
Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marika MIkelsaar

ORCID ID

Contact details

University of Tartu
Faculty of Medicine
Dept of Microbiology
Ravila 19
Tartu
50411
Estonia
+372 (0)737 4173
marika.mikelsaar@ut.ee

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

205T-5

Study information

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

Acronym

TE 7

Study hypothesis

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

Ethics Review Committee on Human Research of the University of Tartu, 13/06/2011, ref: 205T-5

Study design

Randomized placebo-controlled parallel trial

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 use the contact details to request a patient information sheet

Condition

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

Phase

Phase I

Drug names

L. plantarum strain TENSIA supplement

Primary outcome measures

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 trial start date

26/09/2011

Overall trial end date

14/11/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

50, 25 subjects in each arm

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

26/09/2011

Recruitment end date

14/11/2011

Locations

Countries of recruitment

Estonia

Trial participating centre

University of Tartu
Tartu
50411
Estonia

Sponsor information

Organisation

Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)

Sponsor details

Kreutzwaldi 1
51014
Tartu
51014
Estonia
+372 (0) 516 4210
ene.tammsaar@tptak.ee

Sponsor type

Industry

Website

http://www.tptak.ee

Funders

Funder type

Industry

Funder name

Bio-Competence Centre of Healthy Dairy Products LLC (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

Publication citations

Additional files

Editorial Notes

20/09/2016: Publication reference added.