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

Effect of probiotic cheese on blood indices and intestinal microflora of healthy elderly volunteers: a randomised, double-blind, dietary cross-over intervention study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45791894

Enrollment

Registered

2009-04-30

Start date

2009-01-03

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal microflora Nutritional, Metabolic, Endocrine Intestinal microflora

Interventions

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 Colo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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. Food allergy

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Estonia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026