Effect of different doses of L. planatrum TENSIA containing probiotic cheese on clinical parameters of volunteers

Effect of different doses of L. planatrum TENSIA containing probiotic cheese on blood indices and intestinal microflora of healthy adult volunteers: An open label, interventional study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42449576

Enrollment

Registered

2010-03-18

Start date

2010-05-10

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

blood indices and intestinal microflora Nutritional, Metabolic, Endocrine

Interventions

Probiotic cheese consumption Group I of volunteers 100 g probiotic cheese once a day for 3 weeks in a daily dose of probitoic being 10^5 CFU Group II of volunteers 100 g probiotic cheese once a day f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Wish to participate in the study 2. Aged 18 years and over, both sexes 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 5 Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
1. The health indices of study participants are assessed at the recruitment and after 3 weeks of probiotic treatment. 1.1. Height 1.2. Weight 1.3. Body mass index (BMI) 1.4. Blood pressure 2. The self-reported questionnaire is applied containing questions on welfare, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), is filled once a week during the trial 3. Haematological indices will be determined at the recruitment and after 3 weeks of probiotic treatment. by standard laboratory methods using certified assays in the local clinical laboratory (United Laboratories of Tartu University Clinics, Estonia). 3.1. Haemoglobin 3.2. White blood cell count 3.3. Red blood cells count 3.4. Platelet count 4. Routine biochemical indices will be determined at the recruitment and after 3 weeks of probiotic treatment 4.1. Albumin 4.2. Ferritine 4.3. Plasma glucose 4.4. High-sensitive CRP (hs-CRP) 4.5. Total cholesterol 4.6. LDL-cholesterol (LDL) 4.7. HDL-cholesterol (HDL) 4.8. Triglycerides 4.9. Serum creatinine 4.10. Alanine transaminase (ALAT) 4.11. Aspartate transaminase (ASAT) 4.12. Immunoglobulin IgE levels 5. Safety of high doses of TENSIA	—

Measure

Time frame

1. The health indices of study participants are assessed at the recruitment and after 3 weeks of probiotic treatment. 1.1. Height 1.2. Weight 1.3. Body mass index (BMI) 1.4. Blood pressure 2. The self-reported questionnaire is applied containing questions on welfare, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), is filled once a week during the trial 3. Haematological indices will be determined at the recruitment and after 3 weeks of probiotic treatment. by standard laboratory methods using certified assays in the local clinical laboratory (United Laboratories of Tartu University Clinics, Estonia). 3.1. Haemoglobin 3.2. White blood cell count 3.3. Red blood cells count 3.4. Platelet count 4. Routine biochemical indices will be determined at the recruitment and after 3 weeks of probiotic treatment 4.1. Albumin 4.2. Ferritine 4.3. Plasma glucose 4.4. High-sensitive CRP (hs-CRP) 4.5. Total cholesterol 4.6. LDL-cholesterol (LDL) 4.7. HDL-cholesterol (HDL) 4.8. Triglycerides 4.9. Serum creatinine 4.10. Alanine transaminase (ALAT) 4.11. Aspartate transaminase (ASAT) 4.12. Immunoglobulin IgE levels 5. Safety of high doses of TENSIA

—

Secondary

Measure	Time frame
Positive impact on human health	—

Countries

Estonia

Outcome results

None listed

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