Vaginal candidosis Infections and Infestations Candidiasis of vulva and vagina
Conditions
Interventions
The participants were assigned to a treatment sequence using a randomization list which is unknown to the Clinical Investigators and laboratory researchers. Half of the females were treated with PLANT
Sponsors
Proge Farm Srl
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with clinical history of recurrent yeast vaginitis (> 3 relapses within 1 year) 2. Age > 18 years 3. No foods with added probiotics (e.g. yogurts and derivate) and food supplements with probiotics taken in the previous 30 days 4. Ability to follow personal hygiene care 5. The will to cooperate during the study
Exclusion criteria
Exclusion criteria: 1. Women with clinical symptoms of yeast or bacterial vaginitis (e.g. burning, itching, odor fish, vaginal discharge, leucorrhea) 2. Ongoing antimicrobial drugs treatment for vaginal infections 3. Laboratory confirmed bacterial infections (exclusion in case of t0 Nugent score > 7) 4. Menopause 5. Pregnancy (drop-out in case of pregnancy during the study) 6. Chronic antibiotic treatment 7. Chronic corticosteroid treatment 8. Immunodeficiency 9. Diabetes 10. Vaginal probiotics used in the previous 30 days 11. Participation to any clinical studies which could influence genitourinary tract flora
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lactobacillary grade (LBG) assessment of vaginal lactobacilli flora, assessed by microscopic vaginal swab examination at t0 (initial visit - baseline), t45 (after 45 days of treatment), t90 (after 90 days of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Genetic identification of the probiotic strain L. plantarum P17630 using PCR and the vaginal swabs collected during visits at t0 (initial visit - baseline), t45 (after 45 days of treatment), t90 (after 90 days of treatment) 2. Relapses of Candida spp; each patient communicated to the clinician if any relapses occurred during the 90-day follow-up | — |
Countries
Romania
Contacts
Public ContactNicu Trincu
Outcome results
None listed