Flourish HEC to Prevent Recurrence of BV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-22

Study Completion Date

2022-11-15

Brief Summary

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In a population of women with heightened vulvovaginal sensitivity and recurrent bacterial vaginosis (BV), the use of the Flourish HEC Vaginal Care System is being tested for prevention of BV recurrence over six months of use.

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Detailed Description

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BV treated with metronidazole or clindamycin recurs within 3 months in at least 43% of women, requiring additional rounds of antibiotics. Preliminary data show that the use of a commercially available 3-component kit can dramatically reduce BV recurrence over 11 weeks of use. This study tests a similar kit with one component altered - the intravaginal gel is composed of hydroxyethylcellulose rather than aloe, making it less likely to trigger reactions in women with sensitive tissues. The study will examine recurrence of BV, vaginal pH, and vulvovaginal symptoms as in the prior study, though extended to 6 months. Additionally, this study examines changes in the vaginal microbiome using targeted next-generation sequencing with the use of the Flourish HEC system.

Conditions

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Bacterial Vaginosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single group of women with recurrent bacterial vaginosis who elect to participate in the study will be assessed before and after using a vaginal care system.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study group

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).

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

see arm description

Interventions

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

see arm description

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pre-menopausal women between the ages of 18 and 52.
* Diagnosis of recurrent BV: \>= 3 episodes of BV within last year, or \>= 2 episodes of BV within past six months, recorded in medical record
* Desire to use personal hygiene products to avoid recurrence of BV.

Exclusion Criteria

* Known allergy or sensitivity to any other ingredient in the Flourish HEC Vaginal Care System
* Immunosuppressed or immunocompromised individuals
* Known allergy or intolerability to metronidazole
* Anyone who may have mental health disorders triggered by answering questions related to vulvar or vaginal health, by pelvic exams, or self-application of vaginal products
* Known vaginal infection that is not BV or yeast infection
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners

Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No