Safety of potential probiotics in healthy male volunteers Not Applicable
Conditions
Interventions
Healthy volunteer men aged 18-65 without health complaints are recruited. The research material is probiotic capsules used as a food supplement, which contain 4 different strains of lactobacilli with
Sponsors
Competence Centre on Health Technologies (Estonia)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy volunteer men aged 18-65 years without health complaints
Exclusion criteria
Exclusion criteria: 1. Inflammation of the urogenital tract 2. Diabetes 3. Acute/chronic (infectious) disease 4. Cardiovascular disease 5. Food allergy 6. Use of antibiotics within 4 weeks before the study 7. Regular use of NSAID 8. Blood donation within the last month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of the probiotic capsules measured using a bespoke daily questionnaire at baseline and one week at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Levels of blood markers measured using blood analysis and general health conditions measured using a questionnaire are assessed before and at the end of the study (one week later) | — |
Countries
Estonia
Contacts
Public ContactImbi Smidt MSc
Outcome results
None listed