Healthy female Not Applicable
Conditions
Interventions
1. Healthy volunteers will be randomly allocated according to a random number table to one of four groups and will take one capsule per day for 1 week followed by 2 weeks of washout, another 1 week ca
Sponsors
Tervisetehnoloogiate Arenduskeskus AS (Competence Centre on Health Technologies)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Desire to participate 2. Age 18–50 years 3. Signed informed consent 4. Participants considered themselves 'healthy' 5. Screening blood tests (blood glucose, glycated haemoglobin, inflammatory indices, liver and kidney functional tests)
Exclusion criteria
Exclusion criteria: 1. Diabetes and acute infection 2. Food allergy 3. Use of any antimicrobial drug within past month 4. Current use of any regular concomitant medication, including medical preparations, non-steroidal anti-inflammatory drugs and antioxidant vitamins 5. Pregnancy or breastfeeding 6. History or clinical signs of cardiovascular abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the safety and tolerability of consumption of probiotic capsules (5 different L. crispatus strains per capsule) 1.1. blood analysis (C-reactive protein, liver and renal function indices) 1.2. The self-reported questionnaire is applied containing questions on well-being, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, stool frequency) and changes in discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in total Lactobacillus counts in faecal and vaginal samples 2. Gastrointestinal and vaginal colonization of ingested L. crispatus strains 3. Change in Nugent score level | — |
Countries
Estonia
Outcome results
None listed