Skip to main content
OpenTrials
Completed

NCT Number: NCT05386147

Flourish HEC to Prevent Recurrence of BV

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–52 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Pelvic Medicine

Rosemont, Pennsylvania, 19010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)

Device

see arm description

Primary outcomes

  1. Change in vaginal microbiome by next-generation sequencing (NGS)

    Time frame: Baseline to 3 months

    Vaginal swab will be analyzed by commercially available NGS service

  2. Change in vaginal microbiome by next-generation sequencing (NGS)

    Time frame: Baseline to 6 months

    Vaginal swab will be analyzed by commercially available NGS service

  3. Change in vaginal microbiome by next-generation sequencing (NGS)

    Time frame: 3 months to 6 months

    Vaginal swab will be analyzed by commercially available NGS service

  4. Change in vaginal microbiome by Nugent scoring

    Time frame: Baseline to 3 months

    Vaginal smear slide will be Gram stained and Nugent scored

  5. Change in vaginal microbiome by Nugent scoring

    Time frame: Baseline to 6 months

    Vaginal smear slide will be Gram stained and Nugent scored

  6. Change in vaginal microbiome by Nugent scoring

    Time frame: 3 months to 6 months

    Vaginal smear slide will be Gram stained and Nugent scored

  7. BV recurrence

    Time frame: 6 months

    Percentage of women with recurrence of BV during the study after initial cure with routine care, if applicable

Secondary outcomes

  1. Change in vulvovaginal symptoms questionnaire (VSQ) self-report

    Time frame: 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.

  2. Change in vulvovaginal symptoms questionnaire (VSQ) self-report

    Time frame: Baseline 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.

  3. Change in vulvovaginal symptoms questionnaire (VSQ) self-report

    Time frame: 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.

  4. Change in vaginal pH

    Time frame: Baseline to 3 months

    Vaginal pH will be tested using pH strip

  5. Change in vaginal pH

    Time frame: Baseline to 6 months

    Vaginal pH will be tested using pH strip

  6. Change in vaginal pH

    Time frame: 3 months to 6 months

    Vaginal pH will be tested using pH strip

Sponsors and collaborators

Lead sponsor

Vaginal Biome Science

Other

Collaborators

  • Center for Pelvic Health

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 23, 2022
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.