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
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
-
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.