Effect of probiotic cheese on blood indices and intestinal microflora of healthy volunteers
| ISRCTN | ISRCTN38739209 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38739209 |
| Secondary identifying numbers | 158/10 |
- 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
Scientific
Ravila str 19
Tartu
50411
Estonia
| Phone | +372 (0)7 374 179 |
|---|---|
| marika.mikelsaar@ut.ee |
Study information
| Study design | Randomised, double-blind, dietary cross-over intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Probiotic Lactobacillus plantarum-containing cheese |
| Primary outcome measure | 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 study start date | 25/04/2007 |
| Completion date | 20/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 25 adult volunteers (9 men and 16 women) |
| 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
50411
Estonia
Sponsor information
Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre
Industry
Industry
Kreutzwaldi str. 1
Tartu
51014
Estonia
| Phone | +372 (0)731 3403 |
|---|---|
| Ene.Tammsaar@emu.ee | |
| Website | http://www.tptak.ee |
"ROR" |
https://ror.org/02e801388 |
Funders
Funder type
Industry
Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
