Flourish HEC to Prevent Recurrence of BV

Vaginal Biome Science6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Bacterial Vaginosis

Interventions

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

see arm description

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 52 Years

Medical Language ↔ Plain English

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

Locations (1)

Center for Pelvic Medicine

Rosemont, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Vaginal swab will be analyzed by commercially available NGS service

Time frame: Baseline to 3 months

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

Vaginal swab will be analyzed by commercially available NGS service

Time frame: Baseline to 6 months

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

Vaginal swab will be analyzed by commercially available NGS service

Time frame: 3 months to 6 months

Change in vaginal microbiome by Nugent scoring

Vaginal smear slide will be Gram stained and Nugent scored

Time frame: Baseline to 3 months

Change in vaginal microbiome by Nugent scoring

Vaginal smear slide will be Gram stained and Nugent scored

Time frame: Baseline to 6 months

Change in vaginal microbiome by Nugent scoring

Vaginal smear slide will be Gram stained and Nugent scored

Time frame: 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

Time frame: 6 months

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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