Bacterial Vaginosis
Conditions
Keywords
BV recurrence, probiotic, intravaginal gel, vaginal pH, vulvovaginal symptoms questionnaire
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.
Interventions
DEVICEFlourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)
see arm description
Sponsors
Center for Pelvic Health
Vaginal Biome Science
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A single group of women with recurrent bacterial vaginosis who elect to participate in the study will be assessed before and after using a vaginal care system.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vaginal microbiome by next-generation sequencing (NGS) | Baseline to 3 months | Vaginal swab will be analyzed by commercially available NGS service |
| Change in vaginal microbiome by Nugent scoring | Baseline to 3 months | Vaginal smear slide will be Gram stained and Nugent scored |
| BV recurrence | 6 months | Percentage of women with recurrence of BV during the study after initial cure with routine care, if applicable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in vulvovaginal symptoms questionnaire (VSQ) self-report | Baseline to 3 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. |
| Change in vaginal pH | Baseline to 3 months | Vaginal pH will be tested using pH strip |
Countries
United States
Outcome results
None listed