Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05753813
Status:
RECRUITING
Last Update Posted:
2023-03-03
First Post:
2023-01-04
Brief Title:
Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome
Sponsor:
Queens Medical Center
Organization:
Queens Medical Center
Study Overview
Official Title:
Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This project aims to investigate if the contraceptive method Phexxi causes changes to the composition of the vaginal microbiome The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli which could have positive effects in the way of preventing recurrent episodes of BV and candida infections
Detailed Description:
This is a single center prospective trial which comprises of a pre-post study design that will be looking at the vaginal microbiome makeup of participants before and after a four-week course of Phexxi The primary outcomes will be an increase in lactic acid-forming lactobacilli as well as a decrease in patient-reported symptoms of vulvovaginitis
This study will be based at the Queens Medical Center QMC POB1 Suite 1004 Eligible patients will be approached by participating clinicians all doctors providing care at the 1004 clinic to assess interest in study participation The principal investigator will review the weekly schedule for the 1004 clinic and alert the attending physicians of patients who may be eligible for the study based on chart review A HIPAA waiver will be required for this stage of recruitment as the principal investigator would otherwise not be accessing these patients charts The attending physician staffing the 1004 clinic will ask the flagged patients if they are interested in learning about the study and review general study objectives with patients If the patient is interested in participating the research associates will approach the patient to more thoroughly screen then conduct the informed consent process Informed consent will be collected from every participant prior to the start of the study
After obtaining informed consent the research team will review standardized instructions for using the study medication with the patient and the research associate will provide a take-home kit including all of the study materials including instructions for collecting each swab and for returning the samples Samples will be self-collected by participants at their home at intervals specified in the study instructions All materials provided to the patient will be pre-labeled with their study ID protecting each participants PHI No collections will take place in-clinic These materials include all surveys patients diary and all swab vials The three collection points are as follows 1 baseline prior to starting intervention see below for recommendations on collecting baseline swab 2 after completion of the intervention 30 days after baseline collection and 3 30 days after completion of the intervention 60 days after baseline collection
All vaginal swabs must be frozen within 48 hours of collection As such the participants will be asked to send their samples within 24 hours in order to give adequate time for delivery to the storage facility and be asked to collect their specimens between Sunday and Thursday so samples can reach the facility during business hours Freezing will occur at the research site Each patients study kit will include a prepaid shipping envelope which the participant can use to mail or drive their specimen to the research team who will then place it in the freezer until it is ready for analysis
The first phase of the study will include an assessment and classification of patients vaginal microbiome prior to receipt of the intervention To get the best representation of the participants baseline microbiome the participant will be asked to collect their baseline swab no sooner than 10 days after menses as menses-induced changes in the microbiome have been shown to resolve after this time12 For similar reasons if participants are being treated with an acute course of antibiotics or antifungals at the time of recruitment they will be asked to wait 10 days after the completion of their medication course before collecting their baseline swab There will be two additional time points for collection collection 2 at the end of the 30 day intervention and collection 3 30 days after completion of the intervention
Once received at the research site samples will be stored in a specimen freezer at -80 degrees F until all specimens are received at which point they will analyzed using NextGen sequencing a DNA sequencing technology that will identify the genetic makeup of their specimens This will be done to sequence the genome of the bacteria of the microbiome not the patients genetic material The first phase of the study will also include a survey which will collect demographic information from each participant as well as assess patients current acceptability of a vaginal gel for prophylactic use their most bothersome symptoms and how their quality of life is affected by recurrent vulvovaginitis The specific information collected from each participant can be found below in Data Analysis The survey used to measure this will be the Vulvovaginal Symptom Questionnaire VSQ which has been validated for the purposes stated above There will also be an added space in the survey provided for open-ended answers and comments
Measurement for primary outcomes will be done using two separate methods In order to assess for the presence of lactic acid-forming organisms before and after the lactic acid gel intervention NextGen DNA sequencing will be completed on self-collected samples submitted by participants The analysis of these samples will be performed by Dr Miller at an in-house lab run by the UH Maternal Fetal Medicine division In order to assess for patient-experienced symptoms survey B will be administered prior to immediately after and 30 days after intervention
In order to measure our secondary outcome Survey C will be administered at collection points 2 and 3 of the vaginal swabs This survey is a validated tool to assess for the acceptability appropriateness and feasability of an intervention Acceptability of Intervention Measure or AIM Intervention Appropriateness measure or IAM and Feasibility of Intervention Measure or FIM
The intervention will take place on a rolling basis as patient participation will have no bearing on other participants The intervention itself will take place over thirty days 8 pre-filled vaginal inserters with vaginal gel will be provided to each of the participants with verbal and written instructions for application Patients will be instructed to use Phexxi twice per week on the same days every week Throughout the 30 days participants will also be asked to keep a diary of events occurring when they used the product such as intercourse or menses as well as record any symptoms or side effects they noticed when using the product The diary can be sent back with the second specimen vial Disposal of the product may be done in a regular waste basket
Approximately 30 days after completion of the intervention participants will receive an email reminder to collect and send a third collection swab in for analysis This email will also include the link for the third and final set of surveys
This study will be based at the Queens Medical Center QMC POB1 Suite 1004 Eligible patients will be approached by participating clinicians all doctors providing care at the 1004 clinic to assess interest in study participation The principal investigator will review the weekly schedule for the 1004 clinic and alert the attending physicians of patients who may be eligible for the study based on chart review A HIPAA waiver will be required for this stage of recruitment as the principal investigator would otherwise not be accessing these patients charts The attending physician staffing the 1004 clinic will ask the flagged patients if they are interested in learning about the study and review general study objectives with patients If the patient is interested in participating the research associates will approach the patient to more thoroughly screen then conduct the informed consent process Informed consent will be collected from every participant prior to the start of the study
After obtaining informed consent the research team will review standardized instructions for using the study medication with the patient and the research associate will provide a take-home kit including all of the study materials including instructions for collecting each swab and for returning the samples Samples will be self-collected by participants at their home at intervals specified in the study instructions All materials provided to the patient will be pre-labeled with their study ID protecting each participants PHI No collections will take place in-clinic These materials include all surveys patients diary and all swab vials The three collection points are as follows 1 baseline prior to starting intervention see below for recommendations on collecting baseline swab 2 after completion of the intervention 30 days after baseline collection and 3 30 days after completion of the intervention 60 days after baseline collection
All vaginal swabs must be frozen within 48 hours of collection As such the participants will be asked to send their samples within 24 hours in order to give adequate time for delivery to the storage facility and be asked to collect their specimens between Sunday and Thursday so samples can reach the facility during business hours Freezing will occur at the research site Each patients study kit will include a prepaid shipping envelope which the participant can use to mail or drive their specimen to the research team who will then place it in the freezer until it is ready for analysis
The first phase of the study will include an assessment and classification of patients vaginal microbiome prior to receipt of the intervention To get the best representation of the participants baseline microbiome the participant will be asked to collect their baseline swab no sooner than 10 days after menses as menses-induced changes in the microbiome have been shown to resolve after this time12 For similar reasons if participants are being treated with an acute course of antibiotics or antifungals at the time of recruitment they will be asked to wait 10 days after the completion of their medication course before collecting their baseline swab There will be two additional time points for collection collection 2 at the end of the 30 day intervention and collection 3 30 days after completion of the intervention
Once received at the research site samples will be stored in a specimen freezer at -80 degrees F until all specimens are received at which point they will analyzed using NextGen sequencing a DNA sequencing technology that will identify the genetic makeup of their specimens This will be done to sequence the genome of the bacteria of the microbiome not the patients genetic material The first phase of the study will also include a survey which will collect demographic information from each participant as well as assess patients current acceptability of a vaginal gel for prophylactic use their most bothersome symptoms and how their quality of life is affected by recurrent vulvovaginitis The specific information collected from each participant can be found below in Data Analysis The survey used to measure this will be the Vulvovaginal Symptom Questionnaire VSQ which has been validated for the purposes stated above There will also be an added space in the survey provided for open-ended answers and comments
Measurement for primary outcomes will be done using two separate methods In order to assess for the presence of lactic acid-forming organisms before and after the lactic acid gel intervention NextGen DNA sequencing will be completed on self-collected samples submitted by participants The analysis of these samples will be performed by Dr Miller at an in-house lab run by the UH Maternal Fetal Medicine division In order to assess for patient-experienced symptoms survey B will be administered prior to immediately after and 30 days after intervention
In order to measure our secondary outcome Survey C will be administered at collection points 2 and 3 of the vaginal swabs This survey is a validated tool to assess for the acceptability appropriateness and feasability of an intervention Acceptability of Intervention Measure or AIM Intervention Appropriateness measure or IAM and Feasibility of Intervention Measure or FIM
The intervention will take place on a rolling basis as patient participation will have no bearing on other participants The intervention itself will take place over thirty days 8 pre-filled vaginal inserters with vaginal gel will be provided to each of the participants with verbal and written instructions for application Patients will be instructed to use Phexxi twice per week on the same days every week Throughout the 30 days participants will also be asked to keep a diary of events occurring when they used the product such as intercourse or menses as well as record any symptoms or side effects they noticed when using the product The diary can be sent back with the second specimen vial Disposal of the product may be done in a regular waste basket
Approximately 30 days after completion of the intervention participants will receive an email reminder to collect and send a third collection swab in for analysis This email will also include the link for the third and final set of surveys
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None