Flourish HEC to Prevent Recurrence of BV

Study Overview
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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.

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.

Official Title
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Pilot Study to Observe Effects of Flourish HEC Vaginal Care System on Vaginal Microbiome in Women With Recurrent Bacterial Vaginosis

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Device: Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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). | Device: Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)<br>* see arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vaginal microbiome by next-generation sequencing (NGS) | Vaginal swab will be analyzed by commercially available NGS service | Baseline to 3 months | 
| Change in vaginal microbiome by next-generation sequencing (NGS) | Vaginal swab will be analyzed by commercially available NGS service | Baseline to 6 months | 
| Change in vaginal microbiome by next-generation sequencing (NGS) | Vaginal swab will be analyzed by commercially available NGS service | 3 months to 6 months | 
| Change in vaginal microbiome by Nugent scoring | Vaginal smear slide will be Gram stained and Nugent scored | Baseline to 3 months | 
| Change in vaginal microbiome by Nugent scoring | Vaginal smear slide will be Gram stained and Nugent scored | Baseline to 6 months | 
| Change in vaginal microbiome by Nugent scoring | Vaginal smear slide will be Gram stained and Nugent scored | 3 months to 6 months | 
| BV recurrence | Percentage of women with recurrence of BV during the study after initial cure with routine care, if applicable | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vulvovaginal symptoms questionnaire (VSQ) self-report | Vaginal and vulvar symptoms will be self-reported using validated VSQ modified to 4-point Likert scores. VSQ consists of a series of questions, each of which is rated as 0 (never), 1(rarely), 2(sometimes), 3 (frequently). Lower scores are healthier. Each question is analyzed separately; there is no overall score reported. | Baseline to 3 months | 
| Change in vulvovaginal symptoms questionnaire (VSQ) self-report | Vaginal and vulvar symptoms will be self-reported using validated VSQ modified to 4-point Likert scores. VSQ consists of a series of questions, each of which is rated as 0 (never), 1(rarely), 2(sometimes), 3 (frequently). Lower scores are healthier. Each question is analyzed separately; there is no overall score reported. | Baseline to 6 months | 
| Change in vulvovaginal symptoms questionnaire (VSQ) self-report | Vaginal and vulvar symptoms will be self-reported using validated VSQ modified to 4-point Likert scores. VSQ consists of a series of questions, each of which is rated as 0 (never), 1(rarely), 2(sometimes), 3 (frequently). Lower scores are healthier. Each question is analyzed separately; there is no overall score reported. | 3 months to 6 months | 
| Change in vaginal pH | Vaginal pH will be tested using pH strip | Baseline to 3 months | 
| Change in vaginal pH | Vaginal pH will be tested using pH strip | Baseline to 6 months | 
| Change in vaginal pH | Vaginal pH will be tested using pH strip | 3 months to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BV recurrence, probiotic, intravaginal gel, vaginal pH, vulvovaginal symptoms questionnaire