Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis
Condition: Bacterial Vaginosis; Vaginal Flora Imbalance
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Observational

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.
    

Detailed description: 
      Methods:

      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) who currently have BV diagnosed via wet mount and vaginal pH,
      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 GC/ CH and trichomonas if it seems indicated
      per sexual history and/ or has not been screened in the last 3 months. A total of 40 patients
      will be enrolled; 20 in a shorter (12-week) preliminary study without microbiome analysis,
      and 20 in a longer (6-month) study including microbiome analysis.

      Once enrolled, each subject will be assigned a study number by the research nurse and receive
      a packet of study materials from a study physician/clinician or the research nurse as well as
      a "Guide to Completing the BV Trial." This is a booklet containing detailed instructions for
      each day of the study as well as a diary in which participants will record daily symptoms.
      Demographic and past medical history information will also be collected at this visit.

      On the first day of enrollment, subjects will be screened for BV using the Affirm VPIII test,
      the wet mount, vaginal pH and Nugent scoring. The Affirm test, wet mount, and vaginal pH will
      be done in the office, the Nugent scoring will be done by Dr. Vonetta Edwards. Subjects will
      also complete the vulvovaginal symptoms questionnaire (VSQ). If subjects present with either
      BV or yeast infection, they will be treated with standard of care. After the initial visit,
      all subjects will begin to use Balance every day, Restore every other day, and BiopHresh
      every third day until the completion of the study.

      Subjects will return every 6 weeks for the remainder of the study to assess AE/SAE and test
      for BV the same as at the screening visit. These visits and all other study related visits
      will be with either the PI or sub-investigator. If the participant is found to have BV at one
      of these visits they will be treated using standard of care and continue using the system as
      directed. For subjects in the shorter study, subjects will be screened for BV/yeast, vaginal
      pH, and Nugent scoring every 6 weeks. For those in the longer study, at 3 months and 6
      months, the subject will be rescreened for BV using the Affirm VPIII test, vaginal pH and
      Nugent scoring, and will complete the VSQ. At the 6 month visit, they will repeat all the
      same procedures and also have a vaginal swab done for analysis by the Juno Vaginal Microbiome
      Test. They will also be interviewed to obtain clinical experiences during the trial and will
      turn in a journal of daily product use and symptoms completed throughout the study. This will
      be obtained a member of the research team.

      Monitoring of AE / SAE

      The PI or sub-investigator will monitor AEs and SAEs. Sexual Health and Wellness Institute,
      Sponsor of the study, will not interact directly with participants but will have a staff
      member in the role of "Physician Liaison" available to assist physicians/clinicians at all
      times for the duration of the study. To maintain confidentiality, the Physician Liaison is
      the only Sponsor staff that will have access to patient information including patient names
      and patient physician names and contact information.

      Study Oversight

      The study may be prematurely terminated if it is determined that an abnormal number of
      participants experience SAEs directly associated with study materials, as verified and
      reported by their physician/clinician. Study Sponsor (Sexual Health and Wellness Institute)
      will be responsible for making this determination.

      Data Management

      When all participants have completed the study with the participating clinicians,
      participants' diaries and results of swab tests will be collected from participating
      clinicians, and clinical experiences during the trial will be obtained by short in person
      interviews by a member of the research team. Data from the participants' diaries and data
      obtained from interview will be analyzed.
    

Intervention name(s): Flourish Vaginal Care System
Intervention type(s): Combination Product
Intervention description(s): 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.
Observational model: Cohort
Time perspective: Prospective
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.