Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components) for Bacterial Vaginosis

N/A

Waitlist Available

Led By Susan Kellogg-Spadt, PhD, CRNP

Research Sponsored by Vaginal Biome Science

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special kit called the Flourish HEC Vaginal Care System to help women with sensitive tissues and recurring bacterial infections. The kit includes a gentle gel that helps keep the vaginal environment stable and less prone to infections.

Eligible Conditions

Bacterial Vaginosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months to 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

BV recurrence

Change in vaginal microbiome by Nugent scoring

Change in vaginal microbiome by next-generation sequencing (NGS)

Secondary study objectives

Change in vaginal pH

Change in vulvovaginal symptoms questionnaire (VSQ) self-report

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study groupExperimental Treatment1 Intervention

Women with recurrent BV use the Flourish HEC Vaginal Care System, consisting of three components: 1) "Balance" external wash; 2) BioNourish vaginal moisturizing gel (an FDA 510k cleared class II medical device); and 3) BiopHresh homeopathic vaginal suppository with probiotics. All system components are currently available to the public at national retailers. Women will use the system for six months. They will have vaginal microbiome composition (next-generation sequencing and Nugent score) and vaginal pH tested at baseline, 3 months, and 6 months. At each timepoint they will also complete the vulvovaginal symptoms questionnaire (VSQ).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)

2021

N/A

~10

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