Vaginosis, BacterialNCT02272231
Pathogenesis of Bacterial Vaginosis in Women Who Have Sex With Women
An observational study of Vaginosis, Bacterial, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The objectives of this study are to: (1) use cultivation-independent molecular methods to determine the sequence of microbiological events culminating in bacterial vaginosis (BV) among sexually active African American women who have sex with women (AAWSW) and (2) determine if specific Gardnerella vaginalis oligotypes… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginosis, Bacterial
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jan 2019
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Sexually active African American women who have sex with women with normal vaginal flora at baseline (determined based on 0/4 Amsel criteria and a normal Nugent score of 0-3 with no Gardnerella vaginalis morphotypes noted on vaginal Gram stain) will be followed prospectively over a 90 day time period for the development of incident BV.
Screening Inclusion Criteria:
- African American race
- Female Gender
- Age 18-45 years
- History of sexual activity (oral, vaginal, and/or anal) with a female sexual partner during the past 12 months
- Current female sexual partner
- English speaking
- Ability to give written informed consent
Screening Exclusion Criteria:
- Use of antimicrobials (oral and/or vaginal) within the past 14 days
- Known HIV
- Known pregnancy
- Currently on menstrual period
Enrollment Inclusion Criteria:
- No Amsel criteria (i.e. patient currently asymptomatic from vaginal discharge standpoint, has normal vaginal pH, negative whiff test, and no clue cells on saline microscopy)
- Nugent score of 0-3 with no Gardnerella vaginalis morphotypes noted on Gram stain
Enrollment Exclusion Criteria:
- Presence of current vaginal infections (i.e. trichomoniasis or symptomatic vaginal yeast infection)
- Pregnancy
- Reasons for Subsequent Participant Discontinuation after Initial Enrollment**: (1) Duplicate Nugent score reading > 3 (2) Concurrent trichomonas diagnosis - as determined by nucleic acid amplification testing results
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The objectives of this study are to: (1) use cultivation-independent molecular methods to determine the sequence of microbiological events culminating in bacterial vaginosis (BV) among sexually active African American women who have sex with women (AAWSW) and (2) determine if specific Gardnerella vaginalis oligotypes are associated with the development of BV among sexually active AAWSW.
Read the detailed description
Bacterial vaginosis (BV) is the most common cause of vaginal discharge in the U.S. It is associated with adverse outcomes including preterm birth, pelvic inflammatory disease, and increased risk of acquisition and transmission of sexually transmitted infections (STIs), including HIV. Microbiologically, BV is characterized by depletion of lactobacilli that comprise the normal vaginal flora and increases in facultative (Gardnerella vaginalis; GV) and strict anaerobes.
Three out of four Amsel criteria are necessary for the clinical diagnosis of BV and include (1) homogeneous, thin, grayish-white vaginal discharge, (2) vaginal pH >4.5, (3) positive whiff-amine test, and (4) clue cells present on a wet mount of vaginal fluid. BV diagnosis, however, is based most rigorously on Nugent scoring of a Gram stain of vaginal secretions. Optimal vaginal flora, indicative of a predominance of lactobacilli, is represented by a Nugent score of 0-3. Abnormal vaginal flora includes not only what is currently defined as BV (Nugent score 7-10) but also what is referred to as intermediate flora (Nugent score 4-6). For reasons not well understood, BV is very common among women who have sex with women (WSW), perhaps more so than among heterosexual women. Risks for prevalent BV among WSW have included higher numbers of lifetime female sexual partners, shared use of vaginally inserted sex toys, and oral-anal sex. In addition, WSW in monogamous sexual partnerships have a high concordance for the presence or absence of BV. These data support the hypothesis that BV is sexually transmitted.
It is well accepted that BV is caused by a synergistic relationship between a large number of microorganisms including GV and other anaerobics (i.e. BV-associated bacteria; BVAB) however the trigger which initiates these alterations is debated. It is unknown whether BV results from acquisition of GV as the "founder" organism which subsequently leads to the complex changes in the vaginal microbiota associated with BV or whether BV is transmitted as a polymicrobial consortium. GV, as a facultative anaerobe, may be better able to tolerate the high oxidation-reduction (redox) potential of the healthy vaginal microbiome, unlike strict anaerobes. Similar to facultative anaerobes involved in the initiation of oral disease, it is possible that GV, through its metabolic pathways and ability to form a biofilm (perhaps influenced by specific oligotypes), creates a lower redox potential in the vaginal microbiome. This alteration would then cause a marked decrease in lactobacilli and an increase in other BVAB that are normally present in very low concentrations, leading to the BV syndrome. Determining the exact etiology of the agent(s) causing a shift from optimal to abnormal vaginal flora and BV is vital for appropriate treatment and prevention of adverse outcomes. With increasing use of molecular methods, identification of vaginal microorganisms (some uncultivable) to the species level in women with BV has become more feasible. This study will seek to further investigate BV pathogenesis. We hypothesize that sexual exposure to Gardnerella vaginalis is the inciting event leading to the complex changes in vaginal flora associated with BV. If Gardnerella vaginalis is the initial insult, then its appearance and establishment in the vaginal microbiome will be seen in women who develop incident BV prior to increases in other BV-associated bacteria.
Only African American women will be enrolled in this protocol as differences in the composition of vaginal microbial communities of women with and without BV of different racial and ethnic groups have been noted which could confound the results of this study.
- Conditions
- Vaginosis, Bacterial
- Keywords
- women's health, vaginosis, bacterial, african americans
- Medical subject headings
- Vaginosis, Bacterial
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of incident BV
Based on 3 consecutive days of Nugent score readings of 7-10 (vaginal Gram stain result)
Measured: 90 days
Secondary outcomes (1)
Development of vaginal symptoms
vaginal discharge, odor, itch based on participant daily diary information (study questionnaire)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Vaginosis, BacterialStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mississippi Medical Center, Louisiana State University Health Sciences Center in New Orleans, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Dr. Christina Muzny, University of Alabama at Birmingham
- Investigators
- Christina A Muzny, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272231
- Sponsor's protocol ID
- F131127001
- Status last verified
- Jan 2019
- First submitted
- 20 Oct 2014
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data will be shared with statisticians at the University of Mississippi Medical center for statistical analysis.
Publications
Schwebke JR, Muzny CA, Josey WE. Role of Gardnerella vaginalis in the pathogenesis of bacterial vaginosis: a conceptual model. J Infect Dis. 2014 Aug 1;210(3):338-43. doi: 10.1093/infdis/jiu089. Epub 2014 Feb 7.
PubMed 24511102Muzny CA, Schwebke JR. Gardnerella vaginalis: Still a Prime Suspect in the Pathogenesis of Bacterial Vaginosis. Curr Infect Dis Rep. 2013 Apr;15(2):130-5. doi: 10.1007/s11908-013-0318-4.
PubMed 23371405Muzny CA, Sunesara IR, Kumar R, Mena LA, Griswold ME, Martin DH, Lefkowitz EJ, Schwebke JR, Swiatlo E. Characterization of the vaginal microbiota among sexual risk behavior groups of women with bacterial vaginosis. PLoS One. 2013 Nov 13;8(11):e80254. doi: 10.1371/journal.pone.0080254. eCollection 2013.
PubMed 24236175Muzny CA, Sunesara IR, Griswold ME, Kumar R, Lefkowitz EJ, Mena LA, Schwebke JR, Martin DH, Swiatlo E. Association between BVAB1 and high Nugent scores among women with bacterial vaginosis. Diagn Microbiol Infect Dis. 2014 Dec;80(4):321-3. doi: 10.1016/j.diagmicrobio.2014.09.008. Epub 2014 Sep 16.
PubMed 25262105Schwebke JR, Muzny CA, Josey WE. Reply to Hickey and Forney. J Infect Dis. 2014 Nov 15;210(10):1683-4. doi: 10.1093/infdis/jiu304. Epub 2014 May 22. No abstract available.
PubMed 24855685Muzny CA, Sunesara IR, Austin EL, Mena LA, Schwebke JR. Bacterial vaginosis among African American women who have sex with women. Sex Transm Dis. 2013 Sep;40(9):751-5. doi: 10.1097/OLQ.0000000000000004.
PubMed 23949590Muzny CA, Schwebke JR. Editorial commentary: women who have sex with women: a unique population for studying the pathogenesis of bacterial vaginosis. Clin Infect Dis. 2015 Apr 1;60(7):1054-6. doi: 10.1093/cid/ciu1132. Epub 2014 Dec 16. No abstract available.
PubMed 25516182Muzny CA, Schwebke JR. Biofilms: An Underappreciated Mechanism of Treatment Failure and Recurrence in Vaginal Infections. Clin Infect Dis. 2015 Aug 15;61(4):601-6. doi: 10.1093/cid/civ353. Epub 2015 May 1.
PubMed 25935553Muzny CA, Schwebke JR. Accuracy of Self-Report of Sexual Activity among Adolescent Girls: Implications for Interpretation of Vaginal Flora Patterns. mBio. 2015 Jun 23;6(3):e00819. doi: 10.1128/mBio.00819-15. No abstract available.
PubMed 26106081Muzny CA, Blanchard E, Taylor CM, Aaron KJ, Talluri R, Griswold ME, Redden DT, Luo M, Welsh DA, Van Der Pol WJ, Lefkowitz EJ, Martin DH, Schwebke JR. Identification of Key Bacteria Involved in the Induction of Incident Bacterial Vaginosis: A Prospective Study. J Infect Dis. 2018 Aug 14;218(6):966-978. doi: 10.1093/infdis/jiy243.
PubMed 29718358Van Der Pol WJ, Kumar R, Morrow CD, Blanchard EE, Taylor CM, Martin DH, Lefkowitz EJ, Muzny CA. In Silico and Experimental Evaluation of Primer Sets for Species-Level Resolution of the Vaginal Microbiota Using 16S Ribosomal RNA Gene Sequencing. J Infect Dis. 2019 Jan 7;219(2):305-314. doi: 10.1093/infdis/jiy508.
PubMed 30535155Olson KM, Boohaker LJ, Schwebke JR, Aslibekyan S, Muzny CA. Comparisons of vaginal flora patterns among sexual behaviour groups of women: implications for the pathogenesis of bacterial vaginosis. Sex Health. 2018 Feb;15(1):61-67. doi: 10.1071/SH17087.
PubMed 29212588
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenesis of Bacterial Vaginosis in Women Who Have Sex With Women
- ClinicalTrials.gov ID
- NCT02272231
- Acronym / sponsor ID
- F131127001
- Conditions
- Vaginosis, Bacterial
- Keywords
- women's health, vaginosis, bacterial, african americans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of Mississippi Medical Center, Louisiana State University Health Sciences Center in New Orleans, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Sep 2014
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 22 Oct 2014 (estimated)
- 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.
The objectives of this study are to: (1) use cultivation-independent molecular methods to determine the sequence of microbiological events culminating in bacterial vaginosis (BV) among sexually active African American women who have sex with women (AAWSW) and (2) determine if specific Gardnerella vaginalis oligotypes are associated with the development of BV among sexually active AAWSW.
Detailed description
Bacterial vaginosis (BV) is the most common cause of vaginal discharge in the U.S. It is associated with adverse outcomes including preterm birth, pelvic inflammatory disease, and increased risk of acquisition and transmission of sexually transmitted infections (STIs), including HIV. Microbiologically, BV is characterized by depletion of lactobacilli that comprise the normal vaginal flora and increases in facultative (Gardnerella vaginalis; GV) and strict anaerobes.
Three out of four Amsel criteria are necessary for the clinical diagnosis of BV and include (1) homogeneous, thin, grayish-white vaginal discharge, (2) vaginal pH >4.5, (3) positive whiff-amine test, and (4) clue cells present on a wet mount of vaginal fluid. BV diagnosis, however, is based most rigorously on Nugent scoring of a Gram stain of vaginal secretions. Optimal vaginal flora, indicative of a predominance of lactobacilli, is represented by a Nugent score of 0-3. Abnormal vaginal flora includes not only what is currently defined as BV (Nugent score 7-10) but also what is referred to as intermediate flora (Nugent score 4-6). For reasons not well understood, BV is very common among women who have sex with women (WSW), perhaps more so than among heterosexual women. Risks for prevalent BV among WSW have included higher numbers of lifetime female sexual partners, shared use of vaginally inserted sex toys, and oral-anal sex. In addition, WSW in monogamous sexual partnerships have a high concordance for the presence or absence of BV. These data support the hypothesis that BV is sexually transmitted.
It is well accepted that BV is caused by a synergistic relationship between a large number of microorganisms including GV and other anaerobics (i.e. BV-associated bacteria; BVAB) however the trigger which initiates these alterations is debated. It is unknown whether BV results from acquisition of GV as the "founder" organism which subsequently leads to the complex changes in the vaginal microbiota associated with BV or whether BV is transmitted as a polymicrobial consortium. GV, as a facultative anaerobe, may be better able to tolerate the high oxidation-reduction (redox) potential of the healthy vaginal microbiome, unlike strict anaerobes. Similar to facultative anaerobes involved in the initiation of oral disease, it is possible that GV, through its metabolic pathways and ability to form a biofilm (perhaps influenced by specific oligotypes), creates a lower redox potential in the vaginal microbiome. This alteration would then cause a marked decrease in lactobacilli and an increase in other BVAB that are normally present in very low concentrations, leading to the BV syndrome. Determining the exact etiology of the agent(s) causing a shift from optimal to abnormal vaginal flora and BV is vital for appropriate treatment and prevention of adverse outcomes. With increasing use of molecular methods, identification of vaginal microorganisms (some uncultivable) to the species level in women with BV has become more feasible. This study will seek to further investigate BV pathogenesis. We hypothesize that sexual exposure to Gardnerella vaginalis is the inciting event leading to the complex changes in vaginal flora associated with BV. If Gardnerella vaginalis is the initial insult, then its appearance and establishment in the vaginal microbiome will be seen in women who develop incident BV prior to increases in other BV-associated bacteria.
Only African American women will be enrolled in this protocol as differences in the composition of vaginal microbial communities of women with and without BV of different racial and ethnic groups have been noted which could confound the results of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sexually active African American women who have sex with women with normal vaginal flora at baseline (determined based on 0/4 Amsel criteria and a normal Nugent score of 0-3 with no Gardnerella vaginalis morphotypes noted on vaginal Gram stain) will be followed prospectively over a 90 day time period for the development of incident BV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of incident BV
Time frame: 90 days
Based on 3 consecutive days of Nugent score readings of 7-10 (vaginal Gram stain result)
1 secondary outcome
Development of vaginal symptoms
Time frame: 90 days
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 7 Jan 2019.
- Background: PubMed 24511102Schwebke JR, Muzny CA, Josey WE. Role of Gardnerella vaginalis in the pathogenesis of bacterial vaginosis: a conceptual model. J Infect Dis. 2014 Aug 1;210(3):338-43. doi: 10.1093/infdis/jiu089. Epub 2014 Feb 7.
- Background: PubMed 23371405Muzny CA, Schwebke JR. Gardnerella vaginalis: Still a Prime Suspect in the Pathogenesis of Bacterial Vaginosis. Curr Infect Dis Rep. 2013 Apr;15(2):130-5. doi: 10.1007/s11908-013-0318-4.
- Background: PubMed 24236175Muzny CA, Sunesara IR, Kumar R, Mena LA, Griswold ME, Martin DH, Lefkowitz EJ, Schwebke JR, Swiatlo E. Characterization of the vaginal microbiota among sexual risk behavior groups of women with bacterial vaginosis. PLoS One. 2013 Nov 13;8(11):e80254. doi: 10.1371/journal.pone.0080254. eCollection 2013.
- Background: PubMed 25262105Muzny CA, Sunesara IR, Griswold ME, Kumar R, Lefkowitz EJ, Mena LA, Schwebke JR, Martin DH, Swiatlo E. Association between BVAB1 and high Nugent scores among women with bacterial vaginosis. Diagn Microbiol Infect Dis. 2014 Dec;80(4):321-3. doi: 10.1016/j.diagmicrobio.2014.09.008. Epub 2014 Sep 16.
- Background: PubMed 24855685Schwebke JR, Muzny CA, Josey WE. Reply to Hickey and Forney. J Infect Dis. 2014 Nov 15;210(10):1683-4. doi: 10.1093/infdis/jiu304. Epub 2014 May 22. No abstract available.
- Background: PubMed 23949590Muzny CA, Sunesara IR, Austin EL, Mena LA, Schwebke JR. Bacterial vaginosis among African American women who have sex with women. Sex Transm Dis. 2013 Sep;40(9):751-5. doi: 10.1097/OLQ.0000000000000004.
- Background: PubMed 25516182Muzny CA, Schwebke JR. Editorial commentary: women who have sex with women: a unique population for studying the pathogenesis of bacterial vaginosis. Clin Infect Dis. 2015 Apr 1;60(7):1054-6. doi: 10.1093/cid/ciu1132. Epub 2014 Dec 16. No abstract available.
- Background: PubMed 25935553Muzny CA, Schwebke JR. Biofilms: An Underappreciated Mechanism of Treatment Failure and Recurrence in Vaginal Infections. Clin Infect Dis. 2015 Aug 15;61(4):601-6. doi: 10.1093/cid/civ353. Epub 2015 May 1.
- Background: PubMed 26106081Muzny CA, Schwebke JR. Accuracy of Self-Report of Sexual Activity among Adolescent Girls: Implications for Interpretation of Vaginal Flora Patterns. mBio. 2015 Jun 23;6(3):e00819. doi: 10.1128/mBio.00819-15. No abstract available.
- Background: PubMed 29718358Muzny CA, Blanchard E, Taylor CM, Aaron KJ, Talluri R, Griswold ME, Redden DT, Luo M, Welsh DA, Van Der Pol WJ, Lefkowitz EJ, Martin DH, Schwebke JR. Identification of Key Bacteria Involved in the Induction of Incident Bacterial Vaginosis: A Prospective Study. J Infect Dis. 2018 Aug 14;218(6):966-978. doi: 10.1093/infdis/jiy243.
- Background: PubMed 30535155Van Der Pol WJ, Kumar R, Morrow CD, Blanchard EE, Taylor CM, Martin DH, Lefkowitz EJ, Muzny CA. In Silico and Experimental Evaluation of Primer Sets for Species-Level Resolution of the Vaginal Microbiota Using 16S Ribosomal RNA Gene Sequencing. J Infect Dis. 2019 Jan 7;219(2):305-314. doi: 10.1093/infdis/jiy508.
- Background: PubMed 29212588Olson KM, Boohaker LJ, Schwebke JR, Aslibekyan S, Muzny CA. Comparisons of vaginal flora patterns among sexual behaviour groups of women: implications for the pathogenesis of bacterial vaginosis. Sex Health. 2018 Feb;15(1):61-67. doi: 10.1071/SH17087.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with statisticians at the University of Mississippi Medical center for statistical analysis.
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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.
Christina A Muzny, MD principal investigator
University of Alabama at Birmingham
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 Vaginosis, Bacterial, run by University of Alabama at Birmingham 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?
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 7 Jan 2019. 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?
Development of incident BV (time frame: 90 days). 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 NCT02272231, which also lists 12 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 7 Jan 2019.