Flourish HEC to Prevent Recurrence of BV

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Device: Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Rosemont, Pennsylvania, United States, 19010
      • Center for Pelvic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 52 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study group; 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).

Device: Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components); see arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vaginal microbiome by next-generation sequencing (NGS)	Vaginal swab will be analyzed by commercially available NGS service	Baseline to 3 months
Change in vaginal microbiome by next-generation sequencing (NGS)	Vaginal swab will be analyzed by commercially available NGS service	Baseline to 6 months
Change in vaginal microbiome by next-generation sequencing (NGS)	Vaginal swab will be analyzed by commercially available NGS service	3 months to 6 months
Change in vaginal microbiome by Nugent scoring	Vaginal smear slide will be Gram stained and Nugent scored	Baseline to 3 months
Change in vaginal microbiome by Nugent scoring	Vaginal smear slide will be Gram stained and Nugent scored	Baseline to 6 months
Change in vaginal microbiome by Nugent scoring	Vaginal smear slide will be Gram stained and Nugent scored	3 months to 6 months
BV recurrence	Percentage of women with recurrence of BV during the study after initial cure with routine care, if applicable	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 3 months
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.	Baseline to 6 months
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.	3 months to 6 months
Change in vaginal pH	Vaginal pH will be tested using pH strip	Baseline to 3 months
Change in vaginal pH	Vaginal pH will be tested using pH strip	Baseline to 6 months
Change in vaginal pH	Vaginal pH will be tested using pH strip	3 months to 6 months

Collaborators and Investigators

• Sponsor: Vaginal Biome Science
• Collaborators: Center for Pelvic Health
• Investigators: Principal Investigator: Susan Kellogg-Spadt, PhD, CRNP, Center for Pelvic Medicine

Publications and helpful links

General 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

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2021
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: probiotic; vaginal pH; BV recurrence; intravaginal gel; vulvovaginal symptoms questionnaire
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: BV2P0821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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