Safety and efficacy of putative vaginal probiotics in healthy wome
Not Applicable
Completed
- Conditions
- Not ApplicableHealthy female
- Registration Number
- ISRCTN17618579
- Lead Sponsor
- Tervisetehnoloogiate Arenduskeskus AS (Competence Centre on Health Technologies)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. To evaluate the safety and tolerability of consumption of probiotic capsules (5 different L. crispatus strains per capsule)<br> 1.1.blood analysis (C-reactive protein, liver and renal function indices)<br> 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<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Change in total Lactobacillus counts in faecal and vaginal samples<br> 2. Gastrointestinal and vaginal colonization of ingested L. crispatus strains<br> 3. Change in Nugent score level<br>