Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/03/2009
Date assigned
30/04/2009
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

177 /T-13

Study information

Scientific title

Effect of probiotic cheese on blood indices and intestinal microflora of healthy elderly volunteers: a randomised, double-blind, dietary cross-over intervention study

Acronym

Study hypothesis

The consumption of probiotic Lactobacillus plantarum-containing cheese has positive impact on intestinal microbiota and blood indices of healthy volunteers.

Ethics approval

Ethics Review Committee on Human Research of the University of Tartu approved on the 12th December 2008 (ref: 177/T-13)

Study design

Randomised double-blind dietary cross-over intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Intestinal microflora

Intervention

Probiotic cheese consumption versus control cheese consumption. Volunteers were randomly allocated to receive either:
1. 50 g probiotic cheese (containing Lactobacillus plantarum strain 3 x 10^9 Colony Forming Units [CFU] per gram of cheese) (group 1, n = 12) once a day for three weeks
2. 50 g control cheese (group 2, n = 12) once a day for three weeks

After a two-week wash-out period, volunteers were crossed over to another three weeks of probiotic cheese or control cheese administration.

Intervention type

Drug

Phase

Phase I

Drug names

Lactobacillus plantarum

Primary outcome measures

To assess the safety of cheese comprising the probiotic Lactobacillus plantarum strain in healthy elderly subjects. The survival of the probiotic strain in gastrointestinal tract (GIT) and its effect on intestinal microflora and clinical blood indices of healthy volunteers will be measured at the recruitment, after a 3-week of probiotic treatment, after a 2-week wash-out and after a 3-week placebo treatment.

Secondary outcome measures

1. Blood, urine and faecal samples are collected at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out period and after a 3-week placebo treatment
2. The assessment of the health indices of healthy elderly (body mass index, blood pressure), measured at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out period and after a 3-week placebo treatment
3. The self-reported questionnaire is 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
4. To determine haematological indices (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, albumin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), triglyceride and high-sensitive C-reactive protein (hs-CRP), interleukin 6 (IL-6), immunoglobulins (IgA, IgM, IgG) levels will be measured at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out and after a 3-week placebo treatment
5. Biogenic amines from urines samples will be measured at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out period and after a 3-week placebo treatment
6. Faecal samples will be analysed for the changes in the counts of clostridia (including C. difficile), total anaerobes, enterococci, E. coli and lactic acid bacteria

Overall trial start date

03/01/2009

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Wish to participate in the study
2. Aged over 65 years, either sex
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

Senior

Gender

Both

Target number of participants

24 elderly volunteers (both sexes)

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

Recruitment start date

03/01/2009

Recruitment end date

30/04/2009

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

Government

Funder name

Estonian Science Foundation (Estonia) - http://www.etf.ee/

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

EU Structural Funds (Estonia) - http://www.struktuurifondid.ee/

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Enterprise Estonia (Estonia) - http://www.eas.ee

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