Vaginal health Urological and Genital Diseases
Conditions
Interventions
Participants will be screened at the screening visit (Visit 1) to check that all the inclusion criteria and none of the exclusion criteria are met. The eligibility will be confirmed before Visit 2 bas
Sponsors
Danisco Sweeteners Oy (Finland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female 2. Age 18–50 years (fertile age) 3. Caucasian 4. No vaginal infections within the previous 6 months 5. Has not participated in another investigational drug clinical trial within 1 month (30 days) or received an investigational drug within the last month (30 days) before the start of screening 6. No significant changes in daily routines related to dietary/activity patterns 7. Willingness to take dietary supplements 8. Valid contraception for the duration of the study: 8.1. Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy 8.2. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception 8.3. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or bilateral tubal ligation at least six weeks before taking study treatment. 8.4. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject 8.5. Barrier contraceptive (condoms) 9. Willingness to collaboration in completing the binding parts of the study protocol
Exclusion criteria
Exclusion criteria: 1. Vaginal or urinary complaints within 3 months 2. Vaginal pH > 4.5 3. Pregnant or planning pregnancy 4. Breastfeeding 5. History of significant vulvo-vaginal pathological conditions 6. Antibiotic usage during last 3 months 7. Oral corticosteroid usage during last 3 months 8. Use of vulvo-vaginal medication 9. Acquired or congenital immune deficiency 10. Recent history of radiotherapy (within 2 years) 11. Current or prolonged (more than 1 month in last 2 years) use of corticosteroids or other immune modulating medication. Inhaled corticosteroids for asthma are not considered as an exclusion if their usage has begun more than 3 months prior to recruitment 12. Habitual use of probiotic supplementation 13. Menstrual irregularities including menopause 14. On-going diagnosed disease which in the opinion of the investigator makes the participant unfit for the study 15. Intolerance to any of the study products 16. History of alcohol abuse within 2 years 17. History of drug abuse within 2 years 18. Unable to communicate with the investigator 19. Positive culture from swabs at visit 1 or Nugent score >3 (added 05/01/2021)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal colonization of L. acidophilus and L. rhamnosus measured with quantitative PCR at baseline, day 7, day 14 and day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal pH measured with pH test strips baseline, day 7, day 14 and day 21 Exploratory analyses include assessment of vaginal microbiota composition and immunological markers | — |
Countries
Scotland, United Kingdom
Outcome results
None listed