Condition category
Digestive System
Date applied
31/05/2007
Date assigned
02/07/2007
Last edited
02/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marika Mikelsaar

ORCID ID

Contact details

Ravila str 19
Tartu
50411
Estonia
+372 (0)7 374 179
marika.mikelsaar@ut.ee

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

158/10

Study information

Scientific title

Acronym

TAK

Study hypothesis

The consumption of probiotic Lactobacillus plantarum-containing cheese has positive impact on intestinal microflora of healthy volunteers.

Ethics approval

Approved by the Ethics Review Committee on Human Research of the University of Tartu on 26th March 2007 (ref: 158/10).

Study design

Randomised, double-blind, dietary cross-over intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Intestinal microflora of healthy volunteers

Intervention

Probiotic cheese consumption versus regular cheese consumption. Volunteers were randomly allocated to receive either:
1. 50 g probiotic cheese (group 1, n = 12) or control cheese (group 2, n = 12) once a day for three weeks. Probiotic cheese containing Lactobacillus plantarum strain 3 x 10^9 Colony Forming Units [CFU] per gram of cheese
2. After a two-week washout period, volunteers were crossed over to another three weeks of probiotic cheese or control cheese administration

Intervention type

Drug

Phase

Not Specified

Drug names

Probiotic Lactobacillus plantarum-containing cheese

Primary outcome measures

To assess the safety of the novel probiotic Lactobacillus plantarum with antimicrobial properties and the strain containing cheese on healthy subjects. The survival of the probiotic strain in Gastrointestinal Tract (GIT) and its effect on faecal lactoflora, measured on 25/04/07, 16/05/07, 30/05/07 and 20/06/07.

Secondary outcome measures

1. To assess the health indices of healthy adults (body mass index, blood pressure), measured on 25/04/07, 16/05/07, 30/05/07 and 20/06/07
2. The self-reported questionnaire was applied containing questions on welfare, nutritional habits, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), measured once a week during the trial
3. To determine haematological indices (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, albumin, ferritin, Total Cholesterol (TC), Low-Density Lipoprotein cholesterol (LDL), High-Density Lipoprotein cholesterol (HDL), triglyceride and high-sensitive C-Reactive Protein (hsCRP), Interleukin 6 (IL-6), Immunoglobulins (IgA, IgM, IgG) levels, measured on 25/04/07, 16/05/07, 30/05/07 and 20/06/07
4. To determine in urine the content of biogenic amines
5. Faecal samples were analysed for the changes in the counts of clostridia (including C. difficile), total anaerobes, enterococci, E. coli and lactic acid bacteria, collected also at 25/04/07, 16/05/07, 30/05/07 and 20/06/07 and stored at -20°C. Faecal samples are analysed step-by-step during one year
6. Denaturated Gradient Gel Electrophoresis (DGGE) was used to monitor changes in total faecal microflora after cheese consumption, analysis from faecal samples is performed in September 2007

Overall trial start date

25/04/2007

Overall trial end date

20/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Wish to participate in the study
2. Aged 20 to 50 years
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

25 adult volunteers (9 men and 16 women)

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. Pregnancy or breastfeeding
5. Food allergy

Recruitment start date

25/04/2007

Recruitment end date

20/06/2007

Locations

Countries of recruitment

Estonia

Trial participating centre

Ravila str 19
Tartu
50411
Estonia

Sponsor information

Organisation

Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre

Sponsor details

Kreutzwaldi str. 1
Tartu
51014
Estonia
+372 (0)731 3403
Ene.Tammsaar@emu.ee

Sponsor type

Industry

Website

http://www.tptak.ee

Funders

Funder type

Industry

Funder name

Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22863096

Publication citations

  1. Results

    Songisepp E, Hütt P, Rätsep M, Shkut E, Kõljalg S, Truusalu K, Stsepetova J, Smidt I, Kolk H, Zagura M, Mikelsaar M, Safety of a probiotic cheese containing Lactobacillus plantarum Tensia according to a variety of health indices in different age groups., J. Dairy Sci., 2012, 95, 10, 5495-5509, doi: 10.3168/jds.2011-4756.

Additional files

Editorial Notes