Flourish HEC to Prevent Recurrence of BV

Vaginal Biome Science

Status: Completed

Conditions: Bacterial Vaginosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05386147

BV2P0821

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 6 patients

Sex: Female

Ages: 18 to 52 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

Study group

Experimental group

Description:

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:

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