CompletedNot Applicable

Flourish HEC to Prevent Recurrence of BV

United States6 participantsStarted 2021-12-22

Plain-language 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.

Who can participate

Age range

18 Years – 52 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline to 3 months

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

Timeframe: Baseline to 6 months

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

Timeframe: 3 months to 6 months

Change in vaginal microbiome by Nugent scoring

Timeframe: Baseline to 3 months

Change in vaginal microbiome by Nugent scoring

Timeframe: Baseline to 6 months

Change in vaginal microbiome by Nugent scoring

Timeframe: 3 months to 6 months

BV recurrence

Timeframe: 6 months

Trial details

NCT IDNCT05386147

SponsorVaginal Biome Science

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-15

View on ClinicalTrials.gov More Bacterial Vaginosis trials

Who can participate

Age range

18 Years – 52 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline to 3 months

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

Timeframe: Baseline to 6 months

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

Timeframe: 3 months to 6 months

Change in vaginal microbiome by Nugent scoring

Timeframe: Baseline to 3 months

Change in vaginal microbiome by Nugent scoring

Timeframe: Baseline to 6 months

Change in vaginal microbiome by Nugent scoring

Timeframe: 3 months to 6 months

BV recurrence

Timeframe: 6 months