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Flourish HEC to Prevent Recurrence of BV

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)
Sponsored by
Vaginal Biome Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Vaginosis focused on measuring BV recurrence, probiotic, intravaginal gel, vaginal pH, vulvovaginal symptoms questionnaire

Eligibility Criteria

18 Years - 52 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Pelvic Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

Women 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).

Outcomes

Primary Outcome Measures

Change in vaginal microbiome by next-generation sequencing (NGS)
Vaginal swab will be analyzed by commercially available NGS service
Change in vaginal microbiome by next-generation sequencing (NGS)
Vaginal swab will be analyzed by commercially available NGS service
Change in vaginal microbiome by next-generation sequencing (NGS)
Vaginal swab will be analyzed by commercially available NGS service
Change in vaginal microbiome by Nugent scoring
Vaginal smear slide will be Gram stained and Nugent scored
Change in vaginal microbiome by Nugent scoring
Vaginal smear slide will be Gram stained and Nugent scored
Change in vaginal microbiome by Nugent scoring
Vaginal smear slide will be Gram stained and Nugent scored
BV recurrence
Percentage of women with recurrence of BV during the study after initial cure with routine care, if applicable

Secondary Outcome Measures

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.
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.
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.
Change in vaginal pH
Vaginal pH will be tested using pH strip
Change in vaginal pH
Vaginal pH will be tested using pH strip
Change in vaginal pH
Vaginal pH will be tested using pH strip

Full Information

First Posted
May 11, 2022
Last Updated
July 17, 2023
Sponsor
Vaginal Biome Science
Collaborators
Center for Pelvic Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05386147
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
November 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vaginal Biome Science
Collaborators
Center for Pelvic Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
BV recurrence, probiotic, intravaginal gel, vaginal pH, vulvovaginal symptoms questionnaire

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Women 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).
Intervention Type
Device
Intervention Name(s)
Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)
Intervention Description
see arm description
Primary Outcome Measure Information:
Title
Change in vaginal microbiome by next-generation sequencing (NGS)
Description
Vaginal swab will be analyzed by commercially available NGS service
Time Frame
Baseline to 3 months
Title
Change in vaginal microbiome by next-generation sequencing (NGS)
Description
Vaginal swab will be analyzed by commercially available NGS service
Time Frame
Baseline to 6 months
Title
Change in vaginal microbiome by next-generation sequencing (NGS)
Description
Vaginal swab will be analyzed by commercially available NGS service
Time Frame
3 months to 6 months
Title
Change in vaginal microbiome by Nugent scoring
Description
Vaginal smear slide will be Gram stained and Nugent scored
Time Frame
Baseline to 3 months
Title
Change in vaginal microbiome by Nugent scoring
Description
Vaginal smear slide will be Gram stained and Nugent scored
Time Frame
Baseline to 6 months
Title
Change in vaginal microbiome by Nugent scoring
Description
Vaginal smear slide will be Gram stained and Nugent scored
Time Frame
3 months to 6 months
Title
BV recurrence
Description
Percentage of women with recurrence of BV during the study after initial cure with routine care, if applicable
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in vulvovaginal symptoms questionnaire (VSQ) self-report
Description
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.
Time Frame
Baseline to 3 months
Title
Change in vulvovaginal symptoms questionnaire (VSQ) self-report
Description
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.
Time Frame
Baseline to 6 months
Title
Change in vulvovaginal symptoms questionnaire (VSQ) self-report
Description
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.
Time Frame
3 months to 6 months
Title
Change in vaginal pH
Description
Vaginal pH will be tested using pH strip
Time Frame
Baseline to 3 months
Title
Change in vaginal pH
Description
Vaginal pH will be tested using pH strip
Time Frame
Baseline to 6 months
Title
Change in vaginal pH
Description
Vaginal pH will be tested using pH strip
Time Frame
3 months to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Kellogg-Spadt, PhD, CRNP
Organizational Affiliation
Center for Pelvic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Pelvic Medicine
City
Rosemont
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
Results Reference
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Flourish HEC to Prevent Recurrence of BV

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