Intestinal microflora of healthy volunteers Digestive System Gastrointestinal symptoms
Conditions
Interventions
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) onc
Sponsors
Healthy Dairy Products Ltd (Estonia) - Bio-Competence Centre
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Estonia
Outcome results
None listed