An interventional study of Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components) in Bacterial Vaginosis, sponsored by Vaginal Biome Science. Completed at 1 site in United States. Open to female participants aged 18 Years to 52 Years. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Vaginal Biome Science · Not applicable, Interventional, and Prevention
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.
220 studies on the registry are indexed under Vaginosis, Bacterial; 36 are open to participants now.
This study's enrollment of 6 is below the median of 100 across 187 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Vaginal Biome Science is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
see arm description
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months to 6 months
Change in vaginal pH
Vaginal pH will be tested using pH strip
Time frame: Baseline to 3 months
Change in vaginal pH
Vaginal pH will be tested using pH strip
Time frame: Baseline to 6 months
Change in vaginal pH
Vaginal pH will be tested using pH strip
Time frame: 3 months to 6 months
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Vaginal Biome Science