Effect of probiotic cheese on blood indices and intestinal microflora of healthy elderly volunteers

ISRCTN	ISRCTN45791894
DOI	https://doi.org/10.1186/ISRCTN45791894
Protocol serial number	177 /T-13
Sponsor	Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre
Funders	Estonian Science Foundation (Estonia) - http://www.etf.ee/, EU Structural Funds (Estonia) - http://www.struktuurifondid.ee/, Enterprise Estonia (Estonia) - http://www.eas.ee

Submission date: 18/03/2009
Registration date: 30/04/2009
Last edited: 02/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marika Mikelsaar
Scientific

Ravila str 19
Tartu
50411
Estonia

Phone	+372 (0)7 374 179
Email	marika.mikelsaar@ut.ee

Study information

Primary study design	Interventional
Study design	Randomised double-blind dietary cross-over intervention study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	The consumption of probiotic Lactobacillus plantarum-containing cheese has positive impact on intestinal microbiota and blood indices of healthy volunteers.
Ethics approval(s)	Ethics Review Committee on Human Research of the University of Tartu approved on the 12th December 2008 (ref: 177/T-13)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Lactobacillus plantarum
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	30/04/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	24
Key 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
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
Date of first enrolment	03/01/2009
Date of final enrolment	30/04/2009

Locations

Countries of recruitment

Estonia

Study participating centre

Ravila str 19

Tartu
50411
Estonia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes