Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03734523
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2018-11-06
Brief Title:
Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis
Sponsor:
Vaginal Biome Science
Organization:
Vaginal Biome Science
Study Overview
Official Title:
Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womans 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 37 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 pilotfeasibility 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
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 womans 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 37 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 pilotfeasibility 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 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 physicianclinician 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 AESAE 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 BVyeast 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 physiciansclinicians 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 physicianclinician 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
Over a 2 year period women in one academic OBGYN 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 physicianclinician 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 AESAE 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 BVyeast 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 physiciansclinicians 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 physicianclinician 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None