None listed
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: NIL: NIL
Sponsors
Leucine Rich Bio Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy individuals with no known chronic illness. 2. For post-menopausal group: more than or equal to 12 months amenorrhea (not explained by pregnancy or other medical cause). 3. For pre-menopausal group: currently pre-menopausal (menstruating) sampling not during menses. 4. Willing to abstain from vaginal intercourse, douching, or intravaginal products for 48 hours prior to sampling. 5. Willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Current menstruation (sampling must be rescheduled). 2. Pregnancy or breastfeeding. 3. Use of intravaginal antibiotics, antifungals, or probiotic suppositories within the past 2 weeks. 4. Vaginal douching or intravaginal product use in the past 48 hours. 5. Current symptomatic vaginal infection (pruritus, abnormal discharge, odour) or clinically diagnosed vaginitis at screening. 6. Current symptomatic vaginal infection (pruritus, abnormal discharge, odour) or clinically diagnosed vaginitis at screening. 7. Active sexually transmitted infection diagnosed within past 3 months (self-report or medical history). 8. Major gynecologic surgery within 3 months. 9. Chronic illness such as Type 2 diabetes, Hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in vaginal microbial community alpha diversity (Shannon diversity index), relative abundance of key microbiota between post-menopausal and pre-menopausal healthy women.Timepoint: 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Association between menopausal status and vaginal microbiota composition.Timepoint: 1 month | — |
Countries
India
Contacts
Public ContactDr Mukul Maurya
Leucine Rich Bio Pvt Ltd
Outcome results
None listed