Flourish HEC to Prevent Recurrence of BV

Bacterial Vaginosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05386147
• Other study ID #: BV2P0821
• Status: Completed
• Phase: N/A
• Start date: December 22, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: March 2024
• Source: Vaginal Biome Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

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

Locations

Country	Name	City	State
United States	Center for Pelvic Medicine	Rosemont	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Vaginal Biome Science	Center for Pelvic Health

Country where clinical trial is conducted

United States, 

References & 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

Outcome

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