Flourish HEC to Prevent Recurrence of BV

Not Applicable

Completed

• Conditions: Bacterial Vaginosis
• Interventions: Device: Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)

• Registration Number: NCT05386147
• Lead Sponsor: Vaginal Biome Science

Brief Summary

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

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 Timeline

• Study Start: 2021-12-22
• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-23
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in vaginal pH	3 months to 6 months	Vaginal pH will be tested using pH strip
Change in vulvovaginal symptoms questionnaire (VSQ) self-report	3 months to 6 months	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.

Trial Locations

Locations (1)

Center for Pelvic Medicine; 🇺🇸 Rosemont, Pennsylvania, United States