Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis
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|ClinicalTrials.gov Identifier: NCT03734523|
Recruitment Status : Not yet recruiting
First Posted : November 8, 2018
Last Update Posted : November 22, 2019
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. 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 10 week period.
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.
|Condition or disease||Intervention/treatment|
|Bacterial Vaginosis Vaginal Flora Imbalance||Drug: oral metronidazole Device: BV Diary|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Subjects will return at 1-week after starting the system. They will be screened for BV using the wet mount, vaginal pH and Nugent scoring. The wet mount and vaginal pH will be done in the office, the Nugent scoring will be sent to Dr. Deirdre O'Hanlon at UMSOM. If a superinfection with yeast has occurred, they will be treated via standard of care treatments. If BV is confirmed at the one week visit, they will be treated with a 7 day course of oral metronidazole (standard of care). Those that are diagnosed and those that are not diagnosed with BV, will continue to use Balance every day, Restore every other day, and BiopHresh every third day until the completion of the study.
Drug: oral metronidazole
If BV is confirmed at the one week visit, they will be treated with a 7 day course of oral metronidazole (standard of care). Those that are diagnosed and those that are not diagnosed with BV, will continue to use Balance every day, Restore every other day, and BiopHresh every third day until the completion of the study.
Device: BV Diary
Once enrolled, each subject will be assigned a study number and receive a packet of study materials from their physician/clinician 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.
- Vaginal pH Levels [ Time Frame: 10 weeks ]The aim of this study is to determine if Flourish Vaginal Care System aids in re-establishing and maintaining a healthy vaginal microbiome. The healthiest vaginal environments are characterized by optimal acidic vaginal pH levels, the presence of specific strains of lactobacilli.
- BV Recurrence [ Time Frame: 10 weeks ]The secondary aim is to determine if the continued use of Flourish will prevent recurrence of BV over a 10 week period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734523
|Contact: Wendy Strgar||(541) email@example.com|