What side effects are associated with this type of intervention?

The most common treatments for establishing a healthy neovaginal microbiome, such as probiotics and synbiotics, generally have a good safety profile with few side effects. However, potential side effects can include gastrointestinal symptoms like bloating, gas, and diarrhea. In rare cases, there may be a risk of systemic infections, particularly in immunocompromised individuals. Additionally, there is a theoretical concern about the translocation of bacteria across the gut barrier in preterm infants. Overall, these treatments are considered safe for most healthy individuals.

What prior FDA approvals exist?

There is limited specific information on FDA-approved treatments for establishing a healthy neovaginal microbiome in transgender women. However, treatments aimed at maintaining vaginal microbiome health generally include probiotics and prebiotics, which are designed to promote beneficial bacterial growth. These treatments are often used to manage conditions like bacterial vaginosis and yeast infections. The Vaginal Wellness System being studied likely falls into this category, focusing on the use of probiotics to establish a healthy microbiome.

What other types of research exist?

Promising alternatives to the Vaginal Wellness System for establishing a healthy neovaginal microbiome in 2024 include: 1) Probiotic therapies specifically designed for vaginal health, such as Lactobacillus strains that have shown efficacy in maintaining a balanced vaginal microbiome. 2) Synbiotics, which combine probiotics and prebiotics to enhance the growth and activity of beneficial bacteria. 3) Personalized microbiome treatments based on genomic and microbiome profiling to tailor therapies to individual needs. 4) Advances in microbiome transplantation techniques, which involve transferring a healthy microbiome to the neovagina. These alternatives leverage recent scientific advancements to potentially offer more effective and personalized approaches to maintaining vaginal health.

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Flourish Vaginal Care System for Neovaginal Microbiome Health

N/A

Waitlist Available

Led By Christine McGinn, DO

Research Sponsored by Sexual Health and Wellness Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy cisgender women ages 18-52

Transgender women over age 18 who are preparing to undergo gender-confirmation surgery

Must not have

Immunosuppressed

Known (neo)vaginal infection that is not yeast or BV at start of protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collections at time 0, 6 weeks, and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial examines if a store-bought vaginal health kit, called the Flourish Vaginal Care System, can help transgender women who have had gender-confirming surgery develop a healthy vaginal environment. The kit aims to promote good bacteria, similar to what is found in healthy cisgender women. The goal is to improve overall vaginal health and satisfaction for these women.

Who is the study for?

This trial is for healthy cisgender women aged 18-52 and transgender women over age 18 who are planning to have gender-confirmation surgery. Participants should not be allergic to aloe vera or components of the Flourish Vaginal Care system, nor have certain infections or immune suppression.

What is being tested?

The study is testing the Flourish Vaginal Care System's ability to establish a healthy microbiome in neovaginas of transgender women post-surgery, using commercially-available wellness products.

What are the potential side effects?

Potential side effects may include reactions related to sensitivities or allergies to ingredients in the vaginal care products such as aloe vera. Specific side effects will depend on individual tolerances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a healthy woman aged 18-52.

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I am a transgender woman over 18 planning for gender-confirmation surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My immune system is weakened.

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I have a vaginal infection that is not yeast or BV.

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I cannot tolerate Restore gel after my surgery.

Select...

I am not allergic to aloe vera or ingredients in Restore®, Balance, or BiopHresh®.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collections at time 0, 6 weeks, and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collections at time 0, 6 weeks, and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and collections at time 0, 6 weeks, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Vaginal microbiome

Vaginal pH

Secondary study objectives

VSQ

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 3: Cisgender womenExperimental Treatment1 Intervention

This group will use the Flourish Vaginal Care system for 6 months: Balance external wash daily; Restore intravaginal gel every other day at bedtime; BiopHresh homeopathic/probiotic suppository every 3rd day at bedtime through the end of study.

Group II: Group 1: Transgender women using FlourishExperimental Treatment1 Intervention

After gender-confirming surgery, this group will use the Flourish Vaginal Care System for six months, ramping up usage with healing. They will use "Balance" external wash beginning day 6 after surgery; "Restore®" vaginal moisturizing gel on dilators beginning day 6 after surgery; Restore every other day at bedtime with "BiopHresh" homeopathic/probiotic suppository every 3rd day at bedtime beginning week 6 after surgery through end of study at 6 months.

Group III: Group 2: Transgender women not using FlourishActive Control1 Intervention

After gender-confirming surgery, this group will use only KY jelly on dilators beginning day 6 after surgery according to routine care; they will use any standard hygiene product (soap, body wash, etc) of their choice except products used by Group 1 through the end of the study at 6 months.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Treatments aimed at establishing a healthy neovaginal microbiome, such as the Vaginal Wellness System, often involve the use of probiotics and prebiotics. Probiotics introduce beneficial bacteria to the vaginal environment, helping to outcompete harmful pathogens and restore microbial balance. Prebiotics provide nutrients that support the growth of these beneficial bacteria. This is important for neovaginal microbiome patients as a balanced microbiome can prevent infections, reduce inflammation, and improve overall vaginal health.