Clinical trial NCT05386147: Flourish HEC to Prevent Recurrence of BV
Official title: Pilot Study to Observe Effects of Flourish HEC Vaginal Care System on Vaginal Microbiome in Women With Recurrent Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginosis
Keywords: BV recurrence
probiotic
intravaginal gel
vaginal pH
vulvovaginal symptoms questionnaire
Lead sponsor: Vaginal Biome Science
Sponsor class: OTHER
Collaborators: name: Center for Pelvic Health
First posted: 2022-05-23
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in vaginal microbiome by next-generation sequencing (NGS)
timeFrame: Baseline to 3 months
measure: Change in vaginal microbiome by next-generation sequencing (NGS)
timeFrame: Baseline to 6 months
measure: Change in vaginal microbiome by next-generation sequencing (NGS)
timeFrame: 3 months to 6 months
measure: Change in vaginal microbiome by Nugent scoring
timeFrame: Baseline to 3 months
measure: Change in vaginal microbiome by Nugent scoring
timeFrame: Baseline to 6 months
measure: Change in vaginal microbiome by Nugent scoring
timeFrame: 3 months to 6 months
measure: BV recurrence
timeFrame: 6 months
Secondary outcomes:
measure: Change in vulvovaginal symptoms questionnaire (VSQ) self-report
timeFrame: Baseline to 3 months
measure: Change in vulvovaginal symptoms questionnaire (VSQ) self-report
timeFrame: Baseline to 6 months
measure: Change in vulvovaginal symptoms questionnaire (VSQ) self-report
timeFrame: 3 months to 6 months
measure: Change in vaginal pH
timeFrame: Baseline to 3 months
measure: Change in vaginal pH
timeFrame: Baseline to 6 months
measure: Change in vaginal pH
timeFrame: 3 months to 6 months
Other outcomes:
Locations:
city: Rosemont
country: United States
facility: Center for Pelvic Medicine
state: Pennsylvania
Study officials:
affiliation: Center for Pelvic Medicine
name: Susan Kellogg-Spadt, PhD, CRNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chidawanyika, Tamutenda PhD; Cathy Yi, Chung Hwa MD; Kelly-Martin, Rachel; Cleland, Joshua PhD; DuPriest, Elizabeth PhD Preliminary Data from Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent BV [A80], Obstetrics & Gynecology: May 2022 - Volume 139 - Issue - p 24S doi: 10.1097/01.AOG.0000826648.49549.01