Vaginal dysbiosis and vaginal infections Urological and Genital Diseases
Conditions
Interventions
50 postmenopausal women, aged between 45 and 65 years will be subjected to oral administration of a food supplement containing the SynBalance® Femme blend, consisting of Lactiplantibacillus plantarum
Sponsors
SynBalance srl
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women, aged 45-65 years, with last menstrual cycle more than 18 months ago 2. Women with body mass index (BMI) =27 kg/m² 3. Women with vaginal pH =5 4. Postmenopausal women with typical menopausal disorders 5. Women who intend to use the probiotic product and undergo checkups
Exclusion criteria
Exclusion criteria: 1. Women under hormone therapy (HT) 2. Women with BMI >27 kg/m² 3. Women who intend to use probiotic products or that used them in the last 2 weeks 4. Women with a proven allergy to the product 5. Women who have undergone antimicrobial treatment in the last 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composition of the vaginal microbiota. The effect of the probiotic treatment on the initial menopausal vaginal dysbiosis will be evaluated as an increase in lactobacillary presence and an improvement of healthy microbiota. Measured at baseline and 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Vaginal pH measured using litmus paper at baseline and 4 weeks 2. Dosage of pro-inflammatory cytokines (IL-6, IL-1ß, TNF-a and IL-8) measured using human cytokine ELISA kits at baseline and 4 weeks 3. Vaginal well-being measured using the vaginal health index (VHI) at baseline, 4 and 8 weeks | — |
Countries
Italy
Outcome results
None listed