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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

Tracking Information
First Submitted Date November 6, 2018
First Posted Date November 8, 2018
Last Update Posted Date November 22, 2019
Estimated Study Start Date February 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2019)
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.
Original Primary Outcome Measures
 (submitted: November 6, 2018)
Vaginal pH Levels [ Time Frame: 10 weeks ]
The primary outcome measure is to determine if Restore gel aids in reestablishing optimal acidic vaginal pH levels, thereby creating the environment for good lactobacilli to be reintroduced and thrive.
Change History Complete list of historical versions of study NCT03734523 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 18, 2019)
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.
Original Secondary Outcome Measures
 (submitted: November 6, 2018)
BV Recurrence [ Time Frame: 10 weeks ]
The secondary outcome measure is to determine if the continued use of Restore will prevent recurrence over a 10-week period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis
Official Title Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis
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.

Detailed Description

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.

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.

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.

Subjects will be asked to swab the inside of their vagina for vaginal secretions and make a slide for Nugent scoring. This will be done once weekly, on a day when neither Restore or BiopHresh is administered. They will be given hands on and written instructions on how to make the slide. They will give the slides to the study investigator at each visit and these will be hand delivered to Dr. Deirdre O'Hanlon.

Subjects will return every 2 weeks for the remainder of the study to assess AE/SAE and test for BV the same as at the screening visit. 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. After 10 completed weeks, the subject will be rescreened for BV using the wet mount, vaginal pH and Nugent scoring.

Monitoring of AE / SAE

The physician/clinician who referred the patient for participation in the study will monitor AEs and SAEs. Good Clean Love, 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 (Good Clean Love) 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 telephone interviews by the study sponsor. Data from the participants' diaries and data obtained from phone interview will be analyzed.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Bacterial Vaginosis
  • Vaginal Flora Imbalance
Intervention
  • 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.
Study Groups/Cohorts 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.
Interventions:
  • Drug: oral metronidazole
  • Device: BV Diary
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: November 6, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 52 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Wendy Strgar (541) 344-4483 wendys@goodcleanlove.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03734523
Other Study ID Numbers SAIRB-16-0013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sexual Health and Wellness Institute
Study Sponsor Sexual Health and Wellness Institute
Collaborators Not Provided
Investigators Not Provided
PRS Account Sexual Health and Wellness Institute
Verification Date November 2019