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

ISRCTN	ISRCTN38739209
DOI	https://doi.org/10.1186/ISRCTN38739209
Protocol serial number	158/10
Sponsor	Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre
Funder	Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre

Submission date: 31/05/2007
Registration date: 02/07/2007
Last edited: 02/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

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
Scientific title
Study acronym	TAK
Study objectives	The consumption of probiotic Lactobacillus plantarum-containing cheese has positive impact on intestinal microflora of healthy volunteers.
Ethics approval(s)	Approved by the Ethics Review Committee on Human Research of the University of Tartu on 26th March 2007 (ref: 158/10).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Probiotic Lactobacillus plantarum-containing cheese
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	20/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	25
Key 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
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. Pregnancy or breastfeeding 5. Food allergy
Date of first enrolment	25/04/2007
Date of final enrolment	20/06/2007

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