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Pathogenesis of Bacterial Vaginosis in Women Who Have Sex With Women

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT02272231
Collaborator
University of Mississippi Medical Center (Other), Louisiana State University Health Sciences Center in New Orleans (Other), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
42
Enrollment
1
Location
52
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    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 :
    Sep 1, 2014
    Actual Primary Completion Date :
    Jan 1, 2019
    Actual Study Completion Date :
    Jan 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Development of incident BV [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 [90 days]

      vaginal discharge, odor, itch based on participant daily diary information (study questionnaire)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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)

    Investigators

    • Principal Investigator: Christina A Muzny, MD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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:
    Oct 22, 2014
    Last Update Posted:
    Jan 7, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Dr. Christina Muzny, Associate Professor - Med-Infectious Disease, University of Alabama at Birmingham
    women's health
    vaginosis, bacterial
    african americans
    Additional relevant MeSH terms:
    Vaginosis, Bacterial
    Vaginal Diseases

    Study Results

    No Results Posted as of Jan 7, 2019