Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis

NCT03734523 | Completed FDA Device

• 1 other identifier: SAIRB-16-0013
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Background Bacterial Vaginosis is the most common vaginal infection in women in their reproductive years and a difficult one to treat. In the United States, the National Health and Nutrition Examination Survey (NHANES), estimated the prevalence of BV was 29 percent in the general population of women aged 14 to 49 years and 50 percent in African-American women. It is characterized by a shift in vaginal flora from an acidic environment due to acid producing lactobacilli to a mixture of anaerobic and facultative microorganisms. BV causes symptoms of vaginal odor, itching, discharge and irritation and can greatly impact a woman's health, quality of life, sexual relations, self-image and well-being. BV has also been associated with an increased risk of preterm labor, STD acquisition and vaginal cuff cellulitis after hysterectomy6. After treatment with antibiotics, recurrences are common. About 15-30% will have recurrence in 3 months7. Normal vaginal flora is lactobacilli dominant. Lactobacilli maintain vaginal pH in the acidic range and keep the growth of BV associated bacteria at low levels. Lactobacilli also produce proteins with bactericidal activity which help to maintain their dominance. Anything that alters the vaginal flora and changes the pH to a more basic environment may increase the risk of BV. Currently, there are many sexual lubricants and vaginal moisturizers available on the market. It has recently been shown that many of these are hyperosmolar and it is thought that hyperosmolar lubricants can be damaging to the epithelium and may alter the pH of the vagina. It is postulated that lubricants and moisturizers may predispose to BV by altering the pH of the vagina. The Flourish Vaginal Care System, by Good Clean Love, includes the following three products: Restore, a 510K-cleared moisturizing personal lubricant that has been on the market for 3 years. It is available without a prescription. It is formulated to bio-match the vaginal secretions of women with L. crispatus-dominated microbiota. Restore has a pH of 3.7 with racemic 1% lactic acid, and is iso-osmolar with serum. It is, therefore, much less likely to alter the acid base balance of the vagina, and therefore less likely to predispose to BV. BiopHresh Vaginal Probiotic Suppository, a Bio Matched probiotic homeopathic formulation which provides a clinically-tested combination of lactobacilli including L. crispatus and other strains found in the most stable vaginal microbiome. Research has shown as many as 30% of women do not naturally produce these critical strains of lactobacilli. Balance Moisturizing Personal Wash is a gentle, pH-balancing cleanser with soothing botanical extracts, formulated with more than 60% premium aloe. It is made without toxic saponifiers found in most bar soaps and OTC cleansers, which tend to disrupt the cell to cell adhesion barrier8. The aim of this study is to determine if Flourish Vaginal Care System aids in re-establishing and maintaining a healthy vaginal microbiome by restoring the vaginal pH in to the acidic range. The healthiest vaginal environments are characterized by optimal acidic vaginal pH levels, the presence of specific strains of lactobacilli. The secondary aim is to determine if the continued use of Flourish will prevent recurrence of BV over a 6 month period. The third aim is to determine what the vaginal microbiome community state type is after 6 months of Flourish use. This study is designed to be a pilot/feasibility study. The study will compare the subjects to a historical recurrence risk7. It will also assess the ability of subjects to comply with the protocol.

Conditions

Bacterial Vaginosis; Vaginal Flora Imbalance

Outcome Measures

Primary Outcomes (3)

• Vaginal pH Levels

  The first aim of this study is to determine if Flourish Vaginal Care System is able to reduce the vaginal pH to a health level (pH 3.5-4.2) in order to support a healthier vaginal microbiome.

  6 months

• BV recurrence (assessed using Affirm VPIII test, BD Diagnostics)

  The secondary aim is to determine if the continued use of Flourish will prevent recurrence of BV over a 6 month period. Subjects will be tested every 3 months, or more frequently if symptoms of BV or yeast infection develop.

  6 months

• Vaginal microbiome (assessed using the Juno Vaginal Microbiome Test, a next-generation sequencing technology)

  This aim is to determine what the composition of the vaginal microbiome is after six months of using the Flourish Vaginal Care System in women who had recurrent BV. This is a one-time sample collection and analysis at the end of the study.

  6 months

Secondary Outcomes (2)

• Yeast infections (assessed using the Affirm VPIII test)

  6 months

• Protocol compliance via qualitative analysis of daily journal entries.

  6 months

Study Arms (2)

Pilot Group: 12 week study

Premenopausal women between 18 and 52 who have been diagnosed with BV at least once within the past year will be invited to enroll. They will be followed longitudinally for 12 weeks. As this is an observational study, there is no control group. Exclusions: pregnant women, those with allergies/sensitivities to product ingredients or to Diflucan or metronidazole, anyone who is immunocompromised, anyone with known vaginal infection other than BV or yeast, those who may be mentally/emotionally triggered by VSQ questions. We will exclude vulnerable populations: adults unable to consent, individuals too young to consent, prisoners, and pregnant women.

Combination Product: Flourish Vaginal Care System

Study Group: 6 month study

Premenopausal women between 18 and 52 who have been diagnosed with BV at least once within the past year will be invited to enroll. They will be followed longitudinally for six months. As this is an observational study, there is no control group. Exclusions: pregnant women, those with allergies/sensitivities to product ingredients or to Diflucan or metronidazole, anyone who is immunocompromised, anyone with known vaginal infection other than BV or yeast, those who may be mentally/emotionally triggered by VSQ questions. We will exclude vulnerable populations: adults unable to consent, individuals too young to consent, prisoners, and pregnant women.

Combination Product: Flourish Vaginal Care System

Interventions

Flourish Vaginal Care System COMBINATION_PRODUCT

This is not technically an intervention. All women who enroll in the study will be those who have opted to use the Flourish Vaginal Care System. This system is comprised of a vaginal wash (Balance), an intravaginal moisturizing gel (Restore), and a vaginal probiotic supplement (BiopHresh). Balance will be used daily. Restore will be used every other day. BiopHresh will be used twice a week with Restore. All products will be started after the first visit and continue throughout the 6-month study.

Pilot Group: 12 week study; Study Group: 6 month study

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Over a 2 year period, women in one academic OB/GYN clinic, who are patients of the PI and sub-investigator, with a history of at least one prior episode of BV in the past year, (confirmed via medical records) will be approached during a clinical visit regarding their desire to participate in the trial. If the subject chooses to participate after a thorough discussion of the risks and benefits, she will sign the informed consent and be enrolled in the trial. Subjects will be screened as per the providers' discretion for gonorrhea, chlamydia, and trichomonas if it seems indicated per sexual history and/ or has not been screened in the last 3 months. A total of 20 patients will be enrolled.

You may qualify if:

• Cis women aged 18-52 History of at least one prior episode of BV in the past year

You may not qualify if:

• Pregnant Lactating Postmenopausal Immunosuppressed Known allergies to aloe vera or to other components of Restore, Balance or BiopHresh Known allergy or intolerability to po Diflucan or metronidazole Known vaginal infection that is not yeast or BV Mental/emotional triggering by sensitive questions or procedures.

Sponsors & Collaborators

• Vaginal Biome Science: lead
• Concord Hospital: collaborator

Study Sites (1)

Concord Hospital

Concord, New Hampshire, 03301, United States

Location

Related Publications (7)

• Nasioudis D, Linhares IM, Ledger WJ, Witkin SS. Bacterial vaginosis: a critical analysis of current knowledge. BJOG. 2017 Jan;124(1):61-69. doi: 10.1111/1471-0528.14209. Epub 2016 Jul 11.

  PMID: 27396541 BACKGROUND

• Allsworth JE, Peipert JF. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Obstet Gynecol. 2007 Jan;109(1):114-20. doi: 10.1097/01.AOG.0000247627.84791.91.

  PMID: 17197596 BACKGROUND

• Ruiz FO, Pascual L, Giordano W, Barberis L. Bacteriocins and other bioactive substances of probiotic lactobacilli as biological weapons against Neisseria gonorrhoeae. Pathog Dis. 2015 Apr;73(3):ftv013. doi: 10.1093/femspd/ftv013. Epub 2015 Feb 11.

  PMID: 25673666 BACKGROUND

• Edwards D, Panay N. Treating vulvovaginal atrophy/genitourinary syndrome of menopause: how important is vaginal lubricant and moisturizer composition? Climacteric. 2016 Apr;19(2):151-61. doi: 10.3109/13697137.2015.1124259. Epub 2015 Dec 26.

  PMID: 26707589 BACKGROUND

• van de Wijgert JHHM, Jespers V. The global health impact of vaginal dysbiosis. Res Microbiol. 2017 Nov-Dec;168(9-10):859-864. doi: 10.1016/j.resmic.2017.02.003. Epub 2017 Mar 1.

  PMID: 28257809 BACKGROUND

• Larsson PG. Treatment of bacterial vaginosis. Int J STD AIDS. 1992 Jul-Aug;3(4):239-47. doi: 10.1177/095646249200300402. No abstract available.

  PMID: 1504154 BACKGROUND

• Ananthapadmanabhan KP, Moore DJ, Subramanyan K, Misra M, Meyer F. Cleansing without compromise: the impact of cleansers on the skin barrier and the technology of mild cleansing. Dermatol Ther. 2004;17 Suppl 1:16-25. doi: 10.1111/j.1396-0296.2004.04s1002.x.

  PMID: 14728695 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

• Wendy Strgar

  Sexual Health & Wellness Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 8, 2018
• Study Start: July 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)