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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
Sponsor:
Information provided by (Responsible Party):
Sexual Health and Wellness Institute

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. 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

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Group/Cohort Intervention/treatment
Pilot Group
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population

Methods:

Over a 2 year period, women in one academic OBGYN clinic 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 and confirmed with the Nugent score, 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 20 patients will be enrolled.

Criteria

Inclusion:

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

Exclusion:

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


Information from the National Library of Medicine

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


Contacts
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Contact: Wendy Strgar (541) 344-4483 wendys@goodcleanlove.com

Sponsors and Collaborators
Sexual Health and Wellness Institute

Publications:
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Responsible Party: Sexual Health and Wellness Institute
ClinicalTrials.gov Identifier: NCT03734523     History of Changes
Other Study ID Numbers: SAIRB-16-0013
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Genital Diseases, Female
Bacterial Infections
Vaginitis
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents