NCT05386147

Flourish HEC to Prevent Recurrence of BV

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Vaginal Biome Science · Academic / Other
• Sex: Female
• Age: 18 Years – 52 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DEVICE	Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)	see arm description

Timeline

• Start date: 2021-12-22
• Primary completion: 2022-11-15
• Completion: 2022-11-15
• First posted: 2022-05-23
• Last updated: 2024-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study