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Bacterial VaginosisNCT05386147

Flourish HEC to Prevent Recurrence of BV

A study testing Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components) in people with Bacterial Vaginosis, run by Vaginal Biome Science at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 52 years, women only
Conditions the study is for
Bacterial Vaginosis
What is being tested?
Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
22 Dec 2021to 15 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 52 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Pelvic Medicine

    Rosemont, Pennsylvania, 19010

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)
Keywords
BV recurrence, probiotic, intravaginal gel, vaginal pH, vulvovaginal symptoms questionnaire
Medical subject headings
Vaginosis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    see arm description

Study groups in NCT05386147
Study groupRoleWhat they receive
Study groupExperimentalWomen 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).
Receives: Device: Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Vaginal swab will be analyzed by commercially available NGS service

    Measured: Baseline to 3 months

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

    Vaginal swab will be analyzed by commercially available NGS service

    Measured: Baseline to 6 months

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

    Vaginal swab will be analyzed by commercially available NGS service

    Measured: 3 months to 6 months

  4. Change in vaginal microbiome by Nugent scoring

    Vaginal smear slide will be Gram stained and Nugent scored

    Measured: Baseline to 3 months

  5. Change in vaginal microbiome by Nugent scoring

    Vaginal smear slide will be Gram stained and Nugent scored

    Measured: Baseline to 6 months

  6. Change in vaginal microbiome by Nugent scoring

    Vaginal smear slide will be Gram stained and Nugent scored

    Measured: 3 months to 6 months

  7. BV recurrence

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

    Measured: 6 months

Secondary outcomes (6)

  1. 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.

    Measured: Baseline to 3 months

  2. 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.

    Measured: Baseline to 6 months

  3. 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.

    Measured: 3 months to 6 months

  4. Change in vaginal pH

    Vaginal pH will be tested using pH strip

    Measured: Baseline to 3 months

  5. Change in vaginal pH

    Vaginal pH will be tested using pH strip

    Measured: Baseline to 6 months

  6. Change in vaginal pH

    Vaginal pH will be tested using pH strip

    Measured: 3 months to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2022
  2. Study start22 Dec 2021
  3. Primary completion15 Nov 2022
  4. Study completion15 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05386147
Sponsor's protocol ID
BV2P0821
Status last verified
Mar 2024
First submitted
11 May 2022
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components) in people with Bacterial Vaginosis, run by Vaginal Biome Science at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in vaginal microbiome by next-generation sequencing (NGS) (time frame: Baseline to 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05386147, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.

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