Neovaginal Microbiome
Conditions
Keywords
neovagina, microbiome, lactobacillus, transgender, probiotic
Brief summary
This study examines whether use of a commercially-available vaginal wellness system is able to establish a microbiome in transgender women.
Detailed description
Very little is known about the neovaginal microbiome, but it has been described as being a polymicrobial state similar to bacterial vaginosis (BV) in cis women. The Flourish Vaginal Care System is a commercially-available over-the-counter vaginal wellness kit that helps relieve symptoms of BV. This study is intended to determine whether that kit could also help transgender women who have recently undergone gender-confirming surgery to establish a neovaginal microbiome that is dominated by lactobacilli, as observed in healthy cis women. This could increase health and subjective satisfaction of the neovagina. This study examines the (neo)vaginal microbiome in transgender women with and without using Flourish, as well as a group of healthy cisgender women.
Interventions
Flourish includes Restore® vaginal moisturizing gel, a Class II medical device cleared by the FDA, in addition to two other kit components
Sponsors
Vaginal Biome Science
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Two groups of transgender women who have undergone surgery plus a group of healthy cisgender women who have not undergone surgery
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Transgender women over age 18 who are preparing to undergo gender-confirmation surgery. 2. Healthy cisgender women ages 18-52
Exclusion criteria
1. Immunosuppressed 2. Known allergies or sensitivities to aloe vera or to other components of Restore®, Balance, or BiopHresh® 3. Known (neo)vaginal infection that is not yeast or BV at start of protocol 4. Inability to tolerate Restore gel by day 13 after surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal microbiome | Collections at time 0, 6 weeks, and 6 months | Observation of changes in the composition of the vaginal fluid microbiome over six months using commercially available next-generation sequencing kit (16s rRNA). Biomes will be categorized to community state type (Ravel 2011), and genus- or species-level relative abundance will be compared. |
| Vaginal pH | Collections at time 0, 6 weeks, and 6 months | Observation of changes in vaginal pH over six months by pH strip |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VSQ | Collections at time 0, 6 weeks, and 6 months | Responses to the Vulvovaginal Symptoms Questionnaire |
Countries
United States
Outcome results
None listed