scholarly journals Efficacy and safety of a novel vaginal medical device in recurrent bacterial vaginosis: an international multicentre clinical trial

2019 ◽  
Author(s):  
Filippo Murina ◽  
Ciprian Crişan ◽  
Marius Biriş ◽  
Daniela Sîrbu ◽  
Dionisio Franco Barattini ◽  
...  
Keyword(s):  
Bacterial Vaginosis ◽  
Medical Device ◽  
Recurrence Rate ◽  
Vaginal Flora ◽  
Gardnerella Vaginalis ◽  
Lactobacillus Species ◽  
Published Data ◽  
Childbearing Age ◽  
Open Label ◽  
Adverse Pregnancy

ABSTRACTSeveral risk factors have been identified but the etiology and pathogenesis of Bacterial vaginosis (BV) are still not completely understood, and the recurrence rate of BV remains high despite adequate chemotherapy treatment.The primary objective of the study was to assess the effectiveness of a new vaginal medical device, which contains polycarbophil, 0.04 % lauryl glucoside, and glycerides (Polybactum®– Effik Italia), in reducing BV recurrence rate.This was a multicenter, open label, not comparative study performed in Italy and Romania. Female subjects over 18-years-old affected by recurrent BV were included. The latest episode was diagnosed by Amsel criteria 6-9 days before the start of the study and treated with vaginal metronidazole (gel 0.75% mg for 5 days or ovules 500 mg for 7 days). The recurrence was defined by at least 2 episodes in the previous 12 months. Polybactum®vaginal ovules, day 1-4-7, were started within the 12th and the 24th hr after the end of metronidazole therapy and repeated monthly for 3 cycles.The first 41 patients enrolled were evaluated for an interim analysis 6 months after the study started; 2 patients interrupted the trial, leaving 39 evaluable subjects. The recurrence rate was significantly reduced compared to previous published data (10.26% vs 40% p<0.001). In 35 patients without recurrence, the assessment of Lactobacillus vaginal flora performed by phase contrast microscopy evidenced a significant improvement form baseline (p=0.022) The Investigator global assessment of tolerability was excellent in 38 out of 39 cases.IMPORTANCEBacterial vaginosis (BV) is the most common vaginal disorder in women of childbearing age. In BV, Lactobacillus species, which are predominant in a healthy vaginal flora, are replaced by anaerobes, mainly Gardnerella vaginalis. BV is responsible for more than 60% of vulvovaginal infections and has been linked to serious, potentially life-threatening conditions, including: pelvic inflammatory disease, postoperative infections, acquisition and transmission of the human immunodeficiency virus, preterm birth, and several adverse pregnancy outcomes. Our research showed that 3 monthly cycles of Polybactum®ovules administered after one course of metronidazole vaginal therapy can reduce the rate of Bacterial vaginosis recurrence and improve the vaginal milieu, favouring the growth of vaginal lactobacillus species. Taken together our results confirm that Polibactum®is a safe and effective treatment to reduce BV recurrence rate after a first line therapy with metronidazole.

scholarly journals Analysis of adherence, biofilm formation and cytotoxicity suggests a greater virulence potential of Gardnerella vaginalis relative to other bacterial-vaginosis-associated anaerobes

Microbiology ◽  
2010 ◽  
Vol 156 (2) ◽  
pp. 392-399 ◽  
Author(s):  
Jennifer L. Patterson ◽  
Annica Stull-Lane ◽  
Philippe H. Girerd ◽  
Kimberly K. Jefferson
Keyword(s):  
Bacterial Vaginosis ◽  
Cytotoxic Activity ◽  
Bacterial Species ◽  
Opportunistic Pathogen ◽  
Collective Effects ◽  
Gardnerella Vaginalis ◽  
Childbearing Age ◽  
Virulence Potential ◽  
Virulence Properties

Worldwide, bacterial vaginosis (BV) is the most common vaginal disorder in women of childbearing age. BV is characterized by a dramatic shift in the vaginal microflora, involving a relative decrease in lactobacilli, and a proliferation of anaerobes. In most cases of BV, the predominant bacterial species found is Gardnerella vaginalis. However, pure cultures of G. vaginalis do not always result in BV, and asymptomatic women are sometimes colonized with low numbers of G. vaginalis. Thus, there is controversy about whether G. vaginalis is an opportunistic pathogen and the causative agent of many cases of BV, or whether BV is a polymicrobial condition caused by the collective effects of an altered microbial flora. Recent studies of the biofilm-forming potential and cytotoxic activity of G. vaginalis have renewed interest in the virulence potential of this organism. In an effort to tease apart the aetiology of this disorder, we utilized in vitro assays to compare three virulence properties of G. vaginalis relative to other BV-associated anaerobes. We designed a viable assay to analyse bacterial adherence to vaginal epithelial cells, we compared biofilm-producing capacities, and we assessed cytotoxic activity. Of the BV-associated anaerobes tested, only G. vaginalis demonstrated all three virulence properties combined. This study suggests that G. vaginalis is more virulent than other BV-associated anaerobes, and that many of the bacterial species frequently isolated from BV may be relatively avirulent opportunists that colonize the vagina after G. vaginalis has initiated an infection.

scholarly journals Criteria for diagnosis of bacterial vaginosis using the test Femoflor-16

2017 ◽  
Vol 66 (4) ◽  
pp. 57-67 ◽  
Author(s):  
Veronika V. Nazarova ◽  
Elena V. Shipitsyna ◽  
Ekaterina N. Gerasimova ◽  
Alevtina M. Savicheva
Keyword(s):  
Bacterial Vaginosis ◽  
Vaginal Discharge ◽  
Bacterial Load ◽  
Anaerobic Bacteria ◽  
Microscopic Investigation ◽  
Reproductive Age ◽  
Gardnerella Vaginalis ◽  
Nugent Score ◽  
Adverse Pregnancy ◽  
Amsel Criteria

Background. Bacterial vaginosis is disturbance of the balance of the vaginal microflora, associated with a number of infectious diseases of the urogenital tract and adverse pregnancy outcomes. In this country, for the detection of vaginal dysbiotic conditions, the test Femoflor-16 (DNA-Technology, Moscow) is widely used, however interpretation algorithms of this test do not include the category of BV. Aim. The study aimed to elaborate diagnostic criteria for the detection of BV using Femoflor-16 test. Materials and methods. Women of reproductive age addressing a gynecologist with vaginal discharge were enrolled in the study. For clinical diagnosis of BV, the Amsel criteria were used, laboratory analysis for BV was performed via microscopic investigation of vaginal discharge using the Nugent score. Samples of vaginal discharge from all women were analyzed with the test Femoflor-16, intended for characterizing vaginal microbiocenosis using multiplex quantitative real-time PCR. Results. A total of 280 women were included in the study. BV was diagnosed in 86 women (31%) using the Amsel criteria, and in 81 women (29%) using the Nugent score. All groups of anaerobic bacteria included in Femoflor-16 test were shown to be associated with BV, with the exception of bacteria of the genus Mobiluncus, which are detected together with phylogenetically related but not BV-associated bacteria of the genus Corynebacterium. A low amount of lactobacilli (< 10% of total bacterial load) coupled with an elevated amount of Gardnerella vaginalis/Prevotella bivia/Porphyromonas (> 1%) and/or Eubacterium (> 2%) and/or Sneathia/Leptotrichia/Fusobacterium (> 0.1%) and/or Megasphaera/Veillonella/Dialister (> 0.1%) and/or Lachnobacterium/Clostridium (> 0.1%) and/or Peptostreptococcus (> 0.1%) and/or Atopobium vaginae (> 0.2%) detected BV with a sensitivity of 99% and specificity of 93%. Conclusions. Criteria for BV diagnosis using the test Femoflor-16 have been elaborated, which enable to detect BV or exclude it with a sensitivity of 99% and specificity of 93%. These criteria for BV and criteria of the test manufacturers for severe anaerobic dysbiosis determine to a large extent the same category of the vaginal microbiocenosis.

Defining bacterial vaginosis: to BV or not to BV, that is the question

1996 ◽  
Vol 7 (4) ◽  
pp. 233-234 ◽  
Author(s):  
Phillip E Hay ◽  
David Taylor-Robinson
Keyword(s):  
Bacterial Vaginosis ◽  
Vaginal Flora ◽  
Accurate Diagnosis ◽  
Point Of View ◽  
Gardnerella Vaginalis ◽  
Vaginal Smear ◽  
Clinical Criteria ◽  
Observer Error ◽  
History Of ◽  
Lay Public

The history of bacterial vaginosis (BV), now extending over more than 40 years, has been remarkable not only in terms of repeatedly changing the name of the bacterium that we now know as Gardnerella vaginalis but also in relation to what is thought to constitute the condition, what it should be called and how the diagnosis can best be made. The composite clinical criteria are often confusing for the nonspecialist, provide room for inter-observer error, and misinterpretation of just one criterion can lead to considerable over or under diagnosis. There is no doubt that diagnosis should be through a Gram-stained vaginal smear, allowing detection not only of 'full blown' BV but also patterns of vaginal flora that while not in this category are nevertheless abnormal. Accurate diagnosis is important in view of the ever-growing list of other important conditions that may occur as a consequence of the abnormal flora. In addition to this, we raise the question of whether the name and abbreviation BV is the best either scientifically or from the point of view of the lay public. While recognizing that it now may be too ingrained for further change, is it possible to have a better term, at least for lay use?

Sex, thrush and bacterial vaginosis

1997 ◽  
Vol 8 (10) ◽  
pp. 603-608 ◽  
Author(s):  
P E Hay ◽  
A Ugwumadu ◽  
J Chowns
Keyword(s):  
Bacterial Vaginosis ◽  
Sexual Intercourse ◽  
Vaginal Flora ◽  
Unprotected Intercourse ◽  
Women Of Childbearing Age ◽  
Childbearing Age ◽  
Vaginal Smears ◽  
Unprotected Sexual Intercourse ◽  
Nugent Score ◽  
Intermediate Pattern

Summary: Bacterial vaginosis (BV) is the most common cause of vaginal discharge in women of childbearing age. In some women it shows a relapsing and remitting course with apparently spontaneous onset and resolution. There are intermediate patterns of vaginal flora in which lactobacilli and other species co-exist. We asked women with recurrent BV to prepare vaginal smears daily, and to record symptoms, time of menstruation, sexual activity and use of douches or medication. We Gram-stained the smears and assigned a Nugent score for BV, and noted the presence of candida, pus cells, sperm and blood. Eighteen women collected daily vaginal smears for up to 10 months. Forty months of slides were collected in total. Bacterial vaginosis arose spontaneously on 23 occasions. We saw candida arise 11 times. Bacterial vaginosis appeared after candida on 9 of these 11 episodes. We saw BV regress spontaneously 13 times. Nine of these resolutions occurred within 48 h of unprotected sexual intercourse: BV only arose on one occasion within 48 h of unprotected intercourse. The intermediate pattern was seen for up to 10 days, and occurred as BV began or resolved in some women, and sometimes resolved without developing into BV. Bacterial vaginosis arose most often in the first 7 days of a menstrual cycle, and resolved spontaneously most often in mid-cycle. In women with recurrent BV, BV arises most often around the time of menstruation and resolves spontaneously in mid-cycle. Recurrences often follow an episode of candidiasis, and BV often regresses after unprotected sexual intercourse.

Bacterial Vaginosis in a District Genitourinary Medicine Department: Significance of Vaginal Microbiology and Anaerobes

1994 ◽  
Vol 5 (6) ◽  
pp. 405-408 ◽  
Author(s):  
S A Saidi ◽  
D Mandal ◽  
E Curless
Keyword(s):  
Bacterial Vaginosis ◽  
Significant Proportion ◽  
Vaginal Flora ◽  
Gardnerella Vaginalis ◽  
Sexually Active ◽  
Gram Stain ◽  
Medicine Department ◽  
Clinical Criteria ◽  
Genitourinary Medicine ◽  
Std Screening

The aim of this study was to correlate the significance of vaginal microbiology, in particular its anaerobic component, to the presence of bacterial vaginosis (BV), and to review the clinical criteria used in the diagnosis of this condition. Ninety-two female patients who received routine STD screening were studied. After routine history, presence and character of vaginal discharge and vaginal pH were noted, an amine test performed, and a wet stain observed microscopically. Routine Gram stain smears and cultures were prepared. BV was diagnosed clinically in 28 (30%) of our sample, and Gardnerella vaginalis was cultured in 41 patients (45%). Both clue cells and anaerobes were closely associated with each other and both mutually exclusive with the presence of lactobacilli on Gram stain ( P<0.001). BV was found to be strongly associated with the presence of clue cells on the wet film, anaerobes and G. vaginalis. In conclusion, bacterial vaginosis is not only strongly associated with the presence of G. vaginalis in the vaginal flora, but more strongly with the presence of anaerobes. The study suggests that the microaerophile G. vaginalis is a commensal organism in a significant proportion of sexually active women. If the aerobic status of the healthy vagina is disrupted, anaerobes (including Gardnerella) will flourish, producing the clinical picture of bacterial vaginosis.

scholarly journals Gardnerella vaginalis and Prevotella bivia Trigger Distinct and Overlapping Phenotypes in a Mouse Model of Bacterial Vaginosis

2019 ◽  
Vol 220 (7) ◽  
pp. 1099-1108 ◽  
Author(s):  
Nicole M Gilbert ◽  
Warren G Lewis ◽  
Guocai Li ◽  
Dorothy K Sojka ◽  
Jean Bernard Lubin ◽  
...  
Keyword(s):  
Bacterial Vaginosis ◽  
Reproductive Tract ◽  
Adverse Outcomes ◽  
Gardnerella Vaginalis ◽  
Sialidase Activity ◽  
Ascending Infection ◽  
Prevotella Bivia ◽  
Increased Risk ◽  
Adverse Pregnancy ◽  
Tract Infections

AbstractBackgroundBacterial vaginosis (BV) is a common imbalance of the vaginal microbiota characterized by overgrowth of diverse Actinobacteria, Firmicutes, and Gram-negative anaerobes. Women with BV are at increased risk of secondary reproductive tract infections and adverse pregnancy outcomes. However, which specific bacteria cause clinical features of BV is unclear.MethodsWe previously demonstrated that Gardnerella vaginalis could elicit many BV features in mice. In this study, we established a BV model in which we coinfected mice with G. vaginalis and another species commonly found in women with BV: Prevotella bivia.ResultsThis coinfection model recapitulates several aspects of human BV, including vaginal sialidase activity (a diagnostic BV feature independently associated with adverse outcomes), epithelial exfoliation, and ascending infection. It is notable that G. vaginalis facilitated uterine infection by P. bivia.ConclusionsTaken together, our model provides a framework for advancing our understanding of the role of individual or combinations of BV-associated bacteria in BV pathogenesis.

scholarly journals Novel systems analysis elucidates the influence of personalized variation in microbiome composition on metronidazole efficacy in bacterial vaginosis

2020 ◽  
Author(s):  
Christina Lee ◽  
Ryan Cheu ◽  
Melissa Lemke ◽  
Andrew Gustin ◽  
Michael France ◽  
...  
Keyword(s):  
Bacterial Vaginosis ◽  
Reproductive Tract ◽  
Critical Factor ◽  
Female Reproductive Tract ◽  
Drug Uptake ◽  
Gardnerella Vaginalis ◽  
Lactobacillus Species ◽  
Target Species ◽  
Recurrence Rates ◽  
Pre Treatment

Abstract Bacterial vaginosis (BV) is a syndrome of the female reproductive tract associated with adverse reproductive outcomes and characterized by a shift from a Lactobacillus (LB)-dominant vaginal microbiota to a polymicrobial, anaerobic microbiota, consistently colonized by strains of Gardnerella vaginalis (Gv). The first-line treatment for BV is metronidazole (MNZ); however, treatment failure and recurrence rates remain high. To gain insight into complex interactions between target species (Gv) and non-target Lactobacillus species (Lactobacillus iners (Li)) with MNZ and understand their respective roles in efficacy, we developed an ordinary differential equation model that predicts bacterial growth as a function of drug uptake, metabolism, proliferation, and MNZ sensitivity. Model findings revealed a critical factor in MNZ efficacy may be Li sequestration of MNZ, and that efficacy decreases when the relative abundance of Li is higher pre-treatment. These results were validated in Gv and Li co-cultures (p < 0.001), and in two clinical cohorts, finding women with recurrent BV had significantly lower pre-treatment levels of BV-associated bacteria relative to Lactobacillus spp. (p = 0.0366; p = 0.0484). Overall, model results support a mechanism where non-target Lactobacillus species sequester MNZ from BV-associated target species, such as Gv, promoting BV recurrence by reducing MNZ bioavailability.

scholarly journals Lactobacillus Species Detected by 16S rRNA Gene Sequence Isolated from the vaginae of Pregnant Women and its relation to preterm labor

2018 ◽  
Vol 9 (1) ◽  
pp. 160
Author(s):  
Shaimaa Abdulamer Nasir ◽  
Balsam Kahtan Mohammed ◽  
Sameera G.J. Alabsi
Keyword(s):  
16S Rrna ◽  
Bacterial Vaginosis ◽  
Pregnant Women ◽  
Preterm Labor ◽  
Gene Sequence ◽  
Bacterial Colonization ◽  
Vaginal Flora ◽  
Lactobacillus Species ◽  
Rrna Gene ◽  
Protective Agent

Preterm labor is a common and serious obstetric complication that is believed to be multifactorial. Lactobacilli vaginal colonization is proposed as a protective agent against preterm delivery and that women with bacterial vaginosis, with altered vaginal flora in favor of lactobacilli species absence, is a risk factor for increased incidence of preterm labor; however enough controversy is present in available published literature. This study was aimed to evaluate the association between vaginal bacterial composition and the rate of preterm labor in pregnant women. Vaginal swabs form a total of 250 pregnant women were obtained and assessed using the V2-V3 region of the 16S rRNA sequences for an estimation of lactobacilli colonization. These women were followed up for the outcome of pregnancy. Women with predominantly lactobacilli species were significantly less liable for preterm labor than those women who lack lactobacilli species in their vaginal samples, 10.4% versus 64.2% (P<0.001). To evaluate the risk of preterm labor associated with non-lactobacilli bacterial colonization, Odds ratio was estimated and it was 15.39 (95% confidence interval of 7.91- 29.95). This study concluded that the risk of preterm labor is significantly increased with bacterial vaginosis in favor of alteration of vaginal flora with deficient lactobacilli species. Keywords: Lactobacillus; Preterm labor; Gene Sequence

scholarly journals Study on bacterial vaginosis in pregnant women and associated factors on maternal and fetal outcome

2019 ◽  
Vol 8 (9) ◽  
pp. 3459
Author(s):  
Chitti Sudha A. ◽  
G. Kanthi Teja
Keyword(s):  
Bacterial Vaginosis ◽  
Pregnant Women ◽  
Adverse Pregnancy Outcome ◽  
Anaerobic Bacteria ◽  
Fetal Outcome ◽  
Routine Screening ◽  
Gardnerella Vaginalis ◽  
Multiple Sexual Partners ◽  
Clinical Criteria ◽  
Adverse Pregnancy

Background: Bacterial vaginosis (BV) is a condition in which the normal, lactobacillus-predominant vaginal flora is replaced with anaerobic bacteria, gardnerella vaginalis and mycoplasma hominis1. It is one cause of vaginitis among pregnant and non-pregnant women and an extremely prevalent vaginal condition.Methods: The present study was conducted on all antenatal women attending OPD satisfying the inclusion criteria was taken during the study period 1st October 2012 to 30th June 2014 in GSL General Hospital, Rajahmundry was examined for bacterial vaginosis using Nugent score. All pertinent obstetric and neonatal data covering antenatal events during the course of pregnancy, delivery, puerperium and condition of each newborn at the time of birth was collected. BV was detected by both Gramstain (Nugent criteria) and gold standard clinical criteria (Amsel’s composite criteria).Results: In this study bacterial vaginosis is seen in 313 cases of educated women (62.6%) as most of them have got primary education and 187 (37.4%) cases are uneducated. In this study, symptomatic bacterial vaginosis is more common in multigravida (Bladder -23; Discharge -50) 73 (22%) when compared with primigravida 11 (6.5%) probably because of longer period of marital life. In this study antenatal risk factors like previous IUCD (4.2%) use, H/O STD’s (1.4%), husband having h/o of multiple sexual partners (1.8%) are 7.4%.No cases of smoking, alcohol, drug abuse, douching were reported.Conclusions: Both primigravida and multigravida asymptomatic cases are more when compared to symptomatic cases leading to the need for routine screening. Routine screening of antenatal women resulted in the decrease of adverse pregnancy outcome.

scholarly journals Probiotics administered intravaginally as a complementary therapy combined with antibiotics for the treatment of bacterial vaginosis: a systematic review protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e019301 ◽  
Author(s):  
Liyan Ma ◽  
Jianrong Su ◽  
Yanli Su ◽  
Wei Sun ◽  
Zhaoying Zeng
Keyword(s):  
Systematic Review ◽  
Bacterial Vaginosis ◽  
Systematic Reviews ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Published Data ◽  
Cochrane Central Register ◽  
Childbearing Age ◽  
Recurrence Rates

IntroductionBacterial vaginosis (BV) is a highly prevalent vaginal polymicrobial disorder commonly encountered in women of childbearing age. Therapy with only recommended antibiotics results in low cure rates and unacceptably high recurrence rates. The use of probiotics as a complementary approach for use with antibiotics for the treatment of BV remains unclear. This review aims to assess the efficacy of lactobacilli administered intravaginally in conjunction with antibiotics for the treatment of BV.Methods and analysisThe Cochrane Central Register of Controlled Trials in The Cochrane Library, Cochrane Library of Systematic Reviews, Medline/PubMed and Embase will be used to search for articles from database inception to November 2016. Randomised controlled clinical trials using lactobacilli administered intravaginally in conjunction with antibiotics to treat BV will be included. Primary outcome will be the BV cure rate. The recurrence rate will be examined as secondary outcome. Two reviewers will independently select trials and extract data from the original publications. The risk of bias will be assessed according to the Cochrane Risk of Bias tool. We will perform data synthesis using the Review Manager (RevMan) software V.5.2.3. To assess heterogeneity, we will compute the I2statistic.Ethics and disseminationThis study will be a review of published data and it is not necessary to obtain ethical approval. Findings of this systematic review will be published in a peer-reviewed journal.Trial registration numberInternational Prospective Register of Systematic Reviews 2014: CRD42014015079.

Sign in / Sign up

Export Citation Format

Share Document