Vaginosis, Bacterial Clinical Trial
Official title:
Pathogenesis of Bacterial Vaginosis in Women Who Have Sex With Women
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT02558179 -
Diagnosing Bacterial Vaginosis/Vaginitis (BV) Using the Gynecologene Test Method
|
N/A | |
Completed |
NCT02314429 -
Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis
|
Phase 1 | |
Completed |
NCT02139839 -
Exploratory Study to Evaluate the Effects of the Probiotics L. Rhamnosus GR-1 and L. Reuteri RC-14
|
Phase 0 | |
Recruiting |
NCT01448291 -
Effect of the Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring on Vaginal Innate and Inflammatory Biomarkers
|
Phase 4 | |
Recruiting |
NCT03500107 -
Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical Trial
|
N/A | |
Completed |
NCT00153517 -
Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy
|
Phase 2 | |
Completed |
NCT04989543 -
Study of the Composition and Bacterial Diversity of the Vaginal Microbiota in Healthy Versus Pathological Conditions (Bacterial Vaginosis) Using a Targeted Metagenomic Approach (RNA 16s)
|
N/A | |
Completed |
NCT02641717 -
Validity of Patient-Collected Wet Mounts
|
N/A | |
Terminated |
NCT03943823 -
Postmenopausal Pessary Users: Estrogen Versus Trimosan
|
Phase 4 | |
Completed |
NCT03134924 -
Vaginal Practices in Human Immunodeficiency Virus (HIV) Positive Women in Zambia, a Bio-Behavioral Intervention "WASH-2"
|
N/A | |
Completed |
NCT01293643 -
A Study to Compare the Efficacy and Safety of a Combination of Ketoconazole and Clindamycin Compared to Tetracycline/Amphotericin B Combination Cream for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis (P08077)
|
Phase 3 | |
Terminated |
NCT01153958 -
Colposeptine for the Treatment of Bacterial Vaginosis
|
Phase 4 | |
Completed |
NCT00484653 -
Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman
|
N/A | |
Completed |
NCT05649735 -
EFFICACY AND SAFETY OF OVA AND LAVAGE MEDICAL DEVICES IN THE TREATMENT OF NON-SPECIFIC VULVOVAGINITIS
|
N/A | |
Completed |
NCT02860845 -
Use of Boric Acid in Combination With Probiotics for the Treatment of Vaginal Infections
|
Phase 4 | |
Not yet recruiting |
NCT00491270 -
Bacterial Vaginosis Screening and Treatment to Reduce Infective Complications, Abortion and Preterm Delivery
|
Phase 3 | |
Completed |
NCT01055106 -
Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
|
Phase 2 | |
Terminated |
NCT01322971 -
Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility Population
|
N/A | |
Completed |
NCT04171947 -
Vaginal Ovule With Flavonoid Tea Extract for the Correction of Imbalance in the Vaginal Environment
|
N/A | |
Completed |
NCT02392026 -
Safety and Tolerability of Metronidazole Gel 1.3%
|
Phase 4 |