Flourish HEC to Prevent Recurrence of BV

NCT05386147 | Completed FDA Device

• 1 other identifier: BV2P0821
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis

Keywords

BV recurrence; probiotic; intravaginal gel; vaginal pH; vulvovaginal symptoms questionnaire

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• Change in vulvovaginal symptoms questionnaire (VSQ) self-report

  Baseline to 3 months

• Change in vulvovaginal symptoms questionnaire (VSQ) self-report

  Baseline to 6 months

• Change in vulvovaginal symptoms questionnaire (VSQ) self-report

  3 months to 6 months

• Change in vaginal pH

  Baseline to 3 months

• Change in vaginal pH

  Baseline to 6 months

Study Arms (1)

Study group

EXPERIMENTAL

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)

Interventions

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

see arm description

Study group

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vaginal Biome Science: lead
• Center for Pelvic Health: collaborator

Study Sites (1)

Center for Pelvic Medicine

Rosemont, Pennsylvania, 19010, United States

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Susan Kellogg-Spadt, PhD, CRNP

  Center for Pelvic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 23, 2022
• Study Start: December 22, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)