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Pathogenesis of Bacterial Vaginosis in Women Who Have Sex With Women

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ClinicalTrials.gov Identifier: NCT02272231
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : January 7, 2019
University of Mississippi Medical Center
Louisiana State University Health Sciences Center in New Orleans
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Dr. Christina Muzny, University of Alabama at Birmingham

Brief 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 are associated with the development of BV among sexually active AAWSW.

Condition or disease
Vaginosis, Bacterial

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.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pathogenesis of Bacterial Vaginosis in Women Who Have Sex With Women
Study Start Date : September 2014
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Primary Outcome Measures :
  1. Development of incident BV [ Time Frame: 90 days ]
    Based on 3 consecutive days of Nugent score readings of 7-10 (vaginal Gram stain result)

Secondary Outcome Measures :
  1. Development of vaginal symptoms [ Time Frame: 90 days ]
    vaginal discharge, odor, itch based on participant daily diary information (study questionnaire)

Biospecimen Retention:   Samples With DNA
Self-collected vaginal swabs from women participating in this study will be stored for future research purposes related to the study of the vaginal microbiome.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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:

  1. African American race
  2. Female Gender
  3. Age 18-45 years
  4. History of sexual activity (oral, vaginal, and/or anal) with a female sexual partner during the past 12 months
  5. Current female sexual partner
  6. English speaking
  7. Ability to give written informed consent

Screening Exclusion Criteria:

  1. Use of antimicrobials (oral and/or vaginal) within the past 14 days
  2. Known HIV
  3. Known pregnancy
  4. Currently on menstrual period

Enrollment Inclusion Criteria:

  1. 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)
  2. Nugent score of 0-3 with no Gardnerella vaginalis morphotypes noted on Gram stain

Enrollment Exclusion Criteria:

  1. Presence of current vaginal infections (i.e. trichomoniasis or symptomatic vaginal yeast infection)
  2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272231

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
University of Mississippi Medical Center
Louisiana State University Health Sciences Center in New Orleans
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Christina A Muzny, MD University of Alabama at Birmingham

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Responsible Party: Dr. Christina Muzny, Associate Professor - Med-Infectious Disease, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02272231    
Other Study ID Numbers: F131127001
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with statisticians at the University of Mississippi Medical center for statistical analysis.
Keywords provided by Dr. Christina Muzny, University of Alabama at Birmingham:
women's health
vaginosis, bacterial
african americans
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Bacterial Infections
Bacterial Infections and Mycoses