Bacterial VaginosisNCT03734523
Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis
An observational study of Bacterial Vaginosis and Vaginal Flora Imbalance, run by Vaginal Biome Science at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Bacterial Vaginosis, Vaginal Flora Imbalance
- What is being tested?
- Flourish Vaginal Care System
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Cis women aged 18-52 History of at least one prior episode of BV in the past year
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Bacterial Vaginosis, Vaginal Flora Imbalance
- Being tested
- Flourish Vaginal Care System
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flourish Vaginal Care SystemCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Flourish Vaginal Care System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
Yeast infections (assessed using the Affirm VPIII test)
A secondary aim is to determine frequency of yeast infections while using the Flourish Vaginal Care System. Subjects will be tested every 3 months, or more frequently if symptoms of BV or yeast infection develop.
Measured: 6 months
Protocol compliance via qualitative analysis of daily journal entries.
A secondary aim is to determine how well study subjects are able to adhere to the study protocol. This is a descriptive analysis to determine how often women follow protocol as described, and what kinds/magnitude of deviations occur.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Jul 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vaginal Biome Science
- Sponsor type
- University, hospital or other
- Collaborators
- Concord Hospital
- Responsible party
- Sponsor
- Investigators
- Wendy Strgar, Study director, Sexual Health & Wellness Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734523
- Sponsor's protocol ID
- SAIRB-16-0013
- Status last verified
- Jul 2023
- First submitted
- 6 Nov 2018
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27396541Allsworth 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.
PubMed 17197596Ruiz 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.
PubMed 25673666Edwards 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.
PubMed 26707589van 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.
PubMed 28257809Larsson PG. Treatment of bacterial vaginosis. Int J STD AIDS. 1992 Jul-Aug;3(4):239-47. doi: 10.1177/095646249200300402. No abstract available.
PubMed 1504154Ananthapadmanabhan 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.
PubMed 14728695
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT03734523
- Acronym / sponsor ID
- SAIRB-16-0013
- Conditions
- Bacterial Vaginosis, Vaginal Flora Imbalance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Vaginal Biome ScienceUniversity, hospital or other
- Collaborators
- Concord Hospital
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot Group: 12 week study | – | Combination Product: Flourish Vaginal Care SystemPremenopausal 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. |
| Study Group: 6 month study | – | Combination Product: Flourish Vaginal Care SystemPremenopausal 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. |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Cis women aged 18-52 History of at least one prior episode of BV in the past year
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flourish Vaginal Care SystemThis 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. | Combination product | Pilot Group: 12 week study, Study Group: 6 month study |
Primary outcome
Vaginal pH Levels
Time frame: 6 months
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.
BV recurrence (assessed using Affirm VPIII test, BD Diagnostics)
Time frame: 6 months
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.
Vaginal microbiome (assessed using the Juno Vaginal Microbiome Test, a next-generation sequencing technology)
Time frame: 6 months
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.
2 secondary outcomes
Yeast infections (assessed using the Affirm VPIII test)
Time frame: 6 months
Protocol compliance via qualitative analysis of daily journal entries.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Background: PubMed 27396541Nasioudis 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.
- Background: PubMed 17197596Allsworth 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.
- Background: PubMed 25673666Ruiz 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.
- Background: PubMed 26707589Edwards 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.
- Background: PubMed 28257809van 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.
- Background: PubMed 1504154Larsson PG. Treatment of bacterial vaginosis. Int J STD AIDS. 1992 Jul-Aug;3(4):239-47. doi: 10.1177/095646249200300402. No abstract available.
- Background: PubMed 14728695Ananthapadmanabhan 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.
- Individual participant dataSharing planned: No
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Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Strgar study director
Sexual Health & Wellness Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Vaginosis and Vaginal Flora Imbalance, run by Vaginal Biome Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal pH Levels (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03734523, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.