Background Bacterial Vaginosis Research Articles

Bacterial vaginosis after menopause: factors associated and women's experiences: a cross-sectional study of Australian postmenopausal women.

Background Bacterial vaginosis (BV) is the most common cause of vaginal discharge in reproductive age women; however, little is known about it after menopause. We aimed to learn more about BV in Australian postmenopausal women. Methods We conducted an online survey (July-September 2021). Participants were recruited via social media and professional networks and asked about demographic characteristics, sexual history and BV experiences. Outcomes of interest were the proportion who had heard of BV, had BV ever, or had BV after menopause. Factors associated with these outcomes were assessed using logistic regression. Results Of 906 participants, 83% were included in the analysis. Overall, 37.9% had heard of BV, 11.0% reported having a BV diagnosis ever, 6.3% reported having a BV diagnosis after menopause and 4.4% reported having a BV diagnosis only after menopause. Multivariable analysis found that among all women the odds of having a BV diagnosis after menopause were increased for those who had BV before menopause, had douched in the past 12months, or had a previous STI diagnosis. Among those in a sexual relationship, a BV diagnosis after menopause was associated with a BV diagnosis before menopause, or being in a sexual relationship of 5years or less in duration. About half who reported BV after menopause described recurrences, distress, and a detrimental effect on sexual relationships. Conclusions BV in postmenopausal women is associated with sexual activity, and impacts negatively on their lives. Research into BV should not be limited to reproductive age women.

Negative associations between folate and bacterial vaginosis in the NHANES 2001 to 2004

BackgroundBacterial vaginosis (BV) is one of the most common infections among women of reproductive age and accounts for 15–50% of infections globally. The role played by folate in the pathogenesis and progression of BV is poorly understood. The aim of this study was to investigate the association between serum folate, red blood cell (RBC) folate, and BV in American women.Methods1,954 participants from the 2001-2004 National Health and Nutrition Examination Survey (NHANES) program were included in this study. Multiple logistic regression was used to analyze the association between serum folate, RBC folate, and BV, and covariates including race, age, education level, and body mass index were used to construct adjusted models. Stratified analysis was used to explore the stability of the above associations in different populations.ResultsIn the present cross-sectional study, we found that serum folate and RBC folate were inversely associated with the risk of BV. In the fully adjusted model, the risk of BV was reduced by 35% (OR=0.65, 95% CI: 0.51~0.83, p=0.0007) in the highest serum folate group and 32% (OR=0.68, 95% CI: 0.53~0.87, p=0.0023) in the highest RBC folate group compared to the lowest group.ConclusionsThe results of this study indicated that serum folate and RBC folate were inversely associated with the risk of BV folate supplementation may play an important role in the prevention and management of BV.

Association of intermediate Nugent Score and bacterial vaginosis with sexually transmitted infections and vulvovaginal candidiasis.

Background Bacterial vaginosis is a common vaginal syndrome among females, which leads to significant morbidity and complications, if left untreated. The association of bacterial vaginosis with various sexually transmitted infections has been mentioned in previous literature. However, studies on the intermediate Nugent Score are lacking. This study was planned to examine the association of sexually transmitted infections with the intermediate Nugent Score. Materials and Methods The study included was conducted to include females presenting with vaginal discharge, burning micturition, itching, lower abdominal pain and infertility. The Nugent scoring was used to categorize patients into those having normal flora, intermediate or bacterial vaginosis. Conventional and molecular techniques targeting Trichomonas vaginalis, Chlamydia trachomatis, Ureaplasma urealyticum, Mycoplasma hominis, Syphilis, Neisseria gonorrhoeae and vulvovaginal candidiasis were performed. Results A total of 3,531 clinical samples were collected from females with a median age of 28.0 years. The number of patients with bacterial vaginosis and intermediate Nugent Score and positive cases were significantly higher in the 21-35 years age group (P < 0.0001). We observed that the likelihood of test results being positive for Trichomonas vaginalis was higher (P < 0.05), as the abnormality of the vaginal flora increased. Mycoplasma hominis was observed to be significantly higher in the intermediate Nugent Score group than the BV-positive patients (0.6 vs 0.2, P = 0.002). The number of vulvovaginal candidiasis cases in both the bacterial vaginosis-negative and bacterial vaginosis-positive groups were nearly the same (9.3 vs 9.8%). Limitation Individual follow-up couldn't be performed on the patients. Conclusion We observed that the dysbiosis in vaginal microbiota, with an increase in Nugent scoring, was significantly associated with an increased risk for the acquisition of sexually transmitted infections and vulvovaginal candidiasis.

Intravaginal lactic acid gel versus oral metronidazole for treating women with recurrent bacterial vaginosis: the VITA randomised controlled trial

BackgroundBacterial vaginosis is a common and distressing condition for women. Short-term antibiotic treatment is usually clinically effective, but recurrence is common. We assessed the effectiveness of intravaginal lactic acid gel versus oral metronidazole for treating recurrent bacterial vaginosis.MethodsWe undertook an open-label, multicentre, parallel group, randomised controlled trial in nineteen UK sexual health clinics and a university health centre. Women aged ≥ 16 years, with current bacterial vaginosis symptoms and a preceding history of bacterial vaginosis, were randomised in a 1:1 ratio using a web-based minimisation algorithm, to 400 mg twice daily oral metronidazole tablets or 5 ml once daily intravaginal lactic acid gel, for 7 days. Masking of participants was not possible. The primary outcome was participant-reported resolution of symptoms within 2 weeks. Secondary outcomes included time to first recurrence of symptoms, number of recurrences and repeat treatments over 6 months and side effects.ResultsFive hundred and eighteen participants were randomised before the trial was advised to stop recruiting by the Data Monitoring Committee. Primary outcome data were available for 79% (204/259) allocated to metronidazole and 79% (205/259) allocated to lactic acid gel. Resolution of bacterial vaginosis symptoms within 2 weeks was reported in 70% (143/204) receiving metronidazole versus 47% (97/205) receiving lactic acid gel (adjusted risk difference -23·2%; 95% confidence interval -32.3 to -14·0%). In those participants who had initial resolution and for whom 6 month data were available, 51 of 72 (71%) women in the metronidazole group and 32 of 46 women (70%) in the lactic acid gel group had recurrence of symptoms, with median times to first recurrence of 92 and 126 days, respectively. Reported side effects were more common following metronidazole than lactic acid gel (nausea 32% vs. 8%; taste changes 18% vs. 1%; diarrhoea 20% vs. 6%, respectively).ConclusionsMetronidazole was more effective than lactic acid gel for short-term resolution of bacterial vaginosis symptoms, but recurrence is common following both treatments. Lactic acid gel was associated with fewer reported side effects.Trial registrationISRCTN14161293, prospectively registered on 18th September 2017.

Scoping review of the association between bacterial vaginosis and emotional, sexual and social health

BackgroundBacterial vaginosis (BV) is a condition that, if symptomatic, is characterized by discharge and odor, with high recurrence rates even when treated. This study aims to review what literature exists on the association between BV and the emotional, sexual, and social health of women.MethodsMEDLINE, Embase and Web of Science databases were searched from inception until November 2020. Studies reporting an association between women’s emotional, sexual and/or social health and symptomatic BV in a qualitative and/or quantitative manner were included. Selected studies were divided in three categories, i.e. reporting on the emotional, sexual and/or social association. All studies were critically evaluated and discussed.ResultsSixteen studies were included. Concerning emotional health, we found eight studies that calculated the association between stress and BV, in four this was statistically significant. Four qualitative studies on emotional health showed that the severity of the symptoms influenced the impact on women’s lives. All studies on sexual health reported that many women experienced an impact on their relationship and sexual intimacy. Results for social life ranged from no association found to most of the study population showing avoidance behavior.ConclusionThis review shows that symptomatic BV can be associated with diminished emotional, sexual, and social health, but there is too little evidence to state the extent of this association.

Impact of (recurrent) bacterial vaginosis on quality of life and the need for accessible alternative treatments

BackgroundBacterial vaginosis (BV) is one of the most common vaginal dysbiosis in women aged 15–44 years old.MethodsWe administered a cross-sectional, single timepoint survey to women ages 18 years or older and who have had bacterial vaginosis (BV). Women completed an anonymous online survey evaluating the impact of BV on their quality of life, how effective different types of treatments were and the amount of self-diagnosed vs. provider diagnosed BV episodes they had.Results62 participants completed the anonymous online survey. With a self-reported median number of BV episodes in the past year was 4 (IQR 1–7). Among these women 69.8% reported BV had a negative impact on their sexual health, 67.7% on their physical health, 74.6% on their mental health. More than half of the respondents had used probiotics with oral Lactobacillus sp. (53.2%), mainly by oral route, and over a third had used vaginal boric acid (37.1%). Most women were unaware of Lactobacillus crispatus. Lactobacillus probiotics were more likely to be tried by women who were negatively impacted by BV for overall quality of life (p = 0.033), sexual health (p = 0.002), and mental health (p = 0.006) while boric acid use was more likely to be used by women who were negatively impacted by BV for their sexual health (p = 0.008).ConclusionsBV is associated with negative quality of life and the women most impacted are seeking alternative treatments such as probiotics (Lactobacillus) and boric acid. There needs to be improvements in BV treatment that include alternative therapy options that have demonstrated efficacy with standardized composition, formulation and dosage.

Impact of data balancing a multiclass dataset before the creation of association rules to study bacterial vaginosis

Background Bacterial vaginosis is a polymicrobial syndrome in which the homeostasis exerted by the Latobacillus species that protect the vaginal mucosa has been lost. This study explored the data balancing process with the intention of improving the quality of association rules. The article aimed to balance the unbalanced multiclass dataset to improve association rule creation.Methods A dataset with 201 observations and 58 variables was analyzed. A preconstructed dataset was used. The authors collected the data between August 2016 and October 2018 in Tabasco, Mexico. The study population comprised sexually active women ages 18 to 50 who underwent gynecological inspection at the infectious and metabolic diseases research laboratory at the Universidad Juarez Autonoma de Tabasco. To determine the best k-value, the Random-Forest algorithm was used and the balancing was performed with the SMOTE, ROSE, and ADASYN algorithms. The Apriori algorithm created the rules and to select rules with statistical significance, the is.redundant(), is.significant(), and is.maximal() functions and quality metric Fisher’s exact tes were used. The biological validation was carried out by the expert (bacteriologist).Results The ADASYN algorithm at K = 9 the OOB error was zero, this was the best K-values. In the balancing process the ADASYN algorithm show best the performance. From the dataset balanced with ADASYN, the apriori algorithm created the association rules and the selection with the quality metric Fisher’s exact test, and the biological validation reported 13 rules. Gram - bacteria Atopobium vaginae, Gardnerella vaginalis, Megasphaera filotipo 1, Mycoplasma hominis and Ureaplasma parvum were detected by the apriori algorithm from the balanced dataset.Conclusion Balancing improved the creation of association rules to efficiently model the bacteria that cause bacterial vaginosis.

The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis

BackgroundBacterial vaginosis (BV) is the most common cause of vaginal discharge in women of reproductive age, and it is estimated that up to a third of women will experience it at some point in their lives. BV produces an offensive vaginal odour and it is associated with serious sequelae. The most frequently prescribed treatment for BV in the UK is 7-day oral metronidazole but recurrences are common following it. Dequalinium chloride (Fluomizin©) is an anti-infective, antiseptic agent administered as a vaginal tablet. Small studies have shown this to be an effective alternative to antibiotics as a BV treatment. This trial aims to investigate whether dequalinium is as effective as current antibiotic treatments for the treatment of BV 1 month after treatment start.MethodsDEVA is a multi-centre, randomised, open-label, parallel group, non-inferiority trial of dequalinium chloride versus usual care antibiotics for the treatment of BV. Recruitment will take place in 15 GUM clinics in the UK with Leeds Sexual Health also managing remote recruitment via the trial website. Women will be randomised 1:1 to receive dequalinium or usual care antibiotics. The primary outcome is to determine if the proportion of women reporting resolution of BV symptoms 4 weeks after treatment (without the need for additional treatment) is not worse in women treated with dequalinium chloride compared to usual care antibiotics. Questionnaire follow-up will take place 4 and 12 weeks after starting treatment, and remotely recruited patients will also provide a week 4 BV vaginal smear. The sample size is 904.DiscussionThis trial will provide high-quality evidence on the use of dequalinium chloride as a BV treatment, which could result in patients reducing the number of antibiotics they take.Trial registrationISRCTN ISRCTN91800263. Prospectively registered on 20 January 2020.

Vitamin D deficiency increases the risk of bacterial vaginosis during pregnancy: Evidence from a meta-analysis based on observational studies.

Bacterial vaginosis (BV) is the most common microbiological syndrome in women of childbearing age, causing numerous adverse health issues in pregnant women. Several observational studies have discussed the association between vitamin D deficiency and the risk of BV during pregnancy, but the results were inconclusive. Therefore, this meta-analysis aimed to explore the association between vitamin D deficiency and BV risk in pregnant women. We searched four databases, including PubMed, Embase, Cochrane Library, and Web of Science, from their inception to July 2022. Pooled odds ratios (OR) with corresponding 95% confidence intervals (CI) were estimated using random effects models. Additionally, we conducted subgroup analyses to identify the potential sources of between-study heterogeneity. Sensitivity analysis was performed using the method of exclusion, one study at a time. Publication bias was examined using Egger's test and funnel plot. A total of 14 studies from 13 articles including 4,793 participants were eligible for this meta-analysis. The outcome showed that vitamin D deficiency may increase the risk of BV during pregnancy by 54% (OR, 1.54; 95% CI, 1.25-1.91; P < 0.001). In subgroup analyses, positive associations were also found in studies that were: conducted in black women (OR, 1.56; 95% CI, 0.98-2.48; P = 0.060), focused on the first trimester of pregnancy (OR, 2.22; 95% CI, 1.35-3.64; P = 0.002), of high quality (OR, 3.05; 95% CI, 1.26-7.41; P = 0.014), and adjusted for confounders (OR, 1.28; 95% CI, 1.06-1.55; P = 0.012). Sensitivity analysis reported that BV risk during pregnancy resulting from vitamin D deficiency increased by 157% (OR, 2.57; 95% CI, 1.50-4.42; P = 0.001) when removing the first two high-weight studies. Publication bias was observed using Egger's test (t = 3.43, P = 0.005) and a visual funnel plot. This meta-analysis showed that vitamin D deficiency is positively associated with the risk of BV during pregnancy. Further high-quality prospective cohort studies are needed to determine whether vitamin D intake reduces the prevalence of BV in pregnant women.

Is there any association between adherence to the Mediterranean Diet and Dietary Total Antioxidant Capacity with Bacterial Vaginosis? Results from a Case–Control study

BackgroundBacterial vaginosis, BV, is a common inflammatory vaginal dysbiosis. The Mediterranean diet, MD, containing foods rich in antioxidant compounds, is shown to be beneficial for inflammatory conditions. This study aimed to investigate the association between MD adherence and dietary total antioxidant capacity (DTAC) with BV.MethodsThis case–control study was conducted on 143 BV-affected and 151 healthy individuals aged between 15 and 45 years. The Amsel criteria were used to detect newly diagnosed patients with BV by a gynecologist. The 168-item food frequency questionnaire (FFQ) was used to record participants' dietary intakes in the last year. The reported data in the FFQ was used to measure adherence to the MD by calculating the Medi-Lite score and to measure the DTAC by calculating ferric-reducing antioxidant power, FRAP, based on the related databases. Logistic regression models were used to determine the association between Medi-Lite and DTAC and BV odds.ResultsThe highest tertile of Medi-Lite score was associated with a reduced odds of BV in the crude model (Odds Ratio, OR: 0.49, 95% Confidence Interval, 95% CI 0.25, 0.96, P for trend: 0.023). This significant inverse association was not observed in the last model adjusted for age, body mass index (kg/m2), waist circumferences (cm), cigarette smoking, frequency of pregnancy, and physical activity (MET/h/d). In crude and adjusted odels, BV odds decreased in the highest tertile of vegetable (adjusted OR, aOR: 0.32, 95% CI 0.16, 0.63, P for trend: 0.001), fish (aOR: 0.46, 95% CI 0.25, 0.84, P for trend: 0.009), legumes (aOR: 0.26, 95% CI 0.14, 0.50, P for trend < 0.001), and meat (aOR: 0.29, 95% CI 0.15, 0.56, P for trend < 0.001) groups. There was no significant association between DTAC and BV odds.ConclusionsThe significant inverse association between the MD adherence and BV odds did not remain after modifying for confounders; besides, DTAC was not associated with BV odds. However, some of the MD components might be associated with a reduced odds of BV.

Bacterial Vaginosis and Associated Factors Among Pregnant Women Attending Antenatal Care in Harar City, Eastern Ethiopia.

BackgroundBacterial vaginosis is one of the most common causes of abnormal vaginal discharge in women of reproductive age, especially pregnant women. It is characterized by the decrement of lactobacilli and increasing proliferation of diverse anaerobic bacteria. The prevalence of bacterial vaginosis and contributing factors vary between countries, within the same country, and among different populations.ObjectiveThe purpose of this study was to determine the prevalence of bacterial vaginosis and associated factors among pregnant women attending antenatal care from May 5–July 15, 2021 in health-care facilities found in Harar town, eastern Ethiopia.Methods and MaterialsAn institutional-based cross-sectional study was conducted among 248 pregnant women attending antenatal care through systematic random sampling. Data were collected using a structured questionnaire and two vaginal swabs were collected using sterile swabs and transported to the microbiology laboratory. Samples were analyzed using Amsel’s criteria or using Nugent scoring criteria and culture. Data were entered into EpiData version 3.1 and transferred to SPSS version 25 for analysis. Binary logistic regression was used to identify variables associated with bacterial vaginosis. P-value <0.05 was considered statistically significant.ResultsAltogether 248 pregnant women were included in the study. Overall, 21.4% (95% CI: 16, 27) of study participants had bacterial vaginosis. History of sexually transmitted infection (AOR = 6.0, 95% CI: 1.94, 19.07; P = 0.002), history of spontaneous abortion (AOR = 5.8, 95% CI: 1.55, 22.02; P = 0.009), multiple sex partners (AOR = 8.6, 95% CI: 2.93, 25.79; P = 0.000) and having vaginal discharge (AOR = 5.5, 95% CI: 2.48, 12.41; P = 0.000) were significantly associated with bacterial vaginosis.ConclusionThe prevalence of bacterial vaginosis is higher among symptomatic pregnant women and associated with a history of sexually transmitted infection, vaginal discharge, multiple sexual partners and spontaneous abortion.

Metronidazole treatment rapidly reduces genital inflammation through effects on bacterial vaginosis-associated bacteria rather than lactobacilli.

BackgroundBacterial vaginosis (BV) causes genital inflammation and increases HIV risk, whereas a vaginal microbiota dominated by Lactobacillus species is associated with immune quiescence and relative HIV protection. BV treatment reduces genital inflammation, but it is unclear whether this reduction is driven by a decrease in BV-associated bacteria or an increase in Lactobacillus species.METHODSTo evaluate the short-term effect of standard BV treatment on genital immunology and the vaginal microbiota, vaginal swabs were collected immediately before and after metronidazole treatment for BV and analyzed with multiplex ELISA, metagenomic sequencing, and quantitative PCR.RESULTSTopical metronidazole treatment rapidly reduced vaginal levels of proinflammatory cytokines, chemokines, and soluble immune markers of epithelial barrier disruption. Although the vaginal microbiota shifted to dominance by L. iners or L. jensenii, this proportional shift was primarily driven by a 2 to 4 log10–fold reduction in BV-associated bacteria absolute abundance. BV treatment induced no change in the absolute abundance of L. crispatus or L. iners and only minor (<1 log10–fold) increases in L. gasseri and L. jensenii that were not independently associated with reduced inflammation in multivariable models.CONCLUSIONThe genital immune benefits that are associated with Lactobacillus dominance after BV treatment were not directly attributable to an absolute increase in lactobacilli, but rather to the loss of BV-associated bacteria.Trial REGISTRATIONParticipants were recruited as part of a randomized controlled trial (ClinicalTrials.gov NCT02766023) from 2016 to 2019.FUNDINGCanadian Institutes of Health Research (PJT-156123) and the National Institute of Allergy and Infectious Diseases (HHSN2722013000141 and HHSN27200007).

Prevalence, risk factors and adverse pregnancy outcomes of second trimester bacterial vaginosis among pregnant women in Bukavu, Democratic Republic of the Congo.

BackgroundBacterial vaginosis (BV) is the most common gynecological condition in women of reproductive age and associated with adverse pregnancy outcomes. In the Democratic Republic of the Congo (DRC), neonatal mortality rate is as high as 2.8 percent with preterm birth (PTB) and low birth weight (LBW) as leading causes. Because no studies have addressed BV in DRC, we aimed to investigate the prevalence of BV, the risk factors and the association between BV and adverse pregnancy outcomes in a population of pregnant women from Bukavu, DRC.MethodsA total of 533 pregnant women in the second trimester of pregnancy were recruited in the Provincial Reference Hospital of Bukavu, DRC, between January and October 2017, and followed until delivery. Clinical and sociodemographic data of mother and newborn, and data on (vaginal) hygiene practices, sexual behavior and reproductive history were collected. BV was diagnosed by Nugent scoring of Gram-stained vaginal smears. Two multivariate regression models were built to identify risk factors for BV and to investigate BV as a risk factor for adverse pregnancy outcomes.ResultsThe prevalence of BV was 26.3% and approximately half of the women with BV were asymptomatic. Independent risk factors for BV were the use of alternatives to water for intravaginal washing, concurrent partners, unemployed status, the presence of vaginal Candida and clay consumption. BV was independently associated with both LBW and PTB of an infant with LBW.ConclusionThe prevalence of BV in Bukavu is high but in line with the global average. BV was associated with adverse pregnancy outcomes in our study population. Hence, research on modifiable risk factor-based interventions to reduce the prevalence of BV, and on screening/treatment of BV during antenatal care should be explored to reduce neonatal mortality and morbidity.

Bacterial vaginosis and other infections in pregnant women in Senegal

BackgroundBacterial vaginosis (BV) is associated with a higher risk of preterm delivery and spontaneous abortion. Yet little data on BV prevalence exist for sub-Saharan countries. The aim of this study was to estimate the prevalence of bacterial vaginosis and associated risk factors among pregnant women in Senegal.MethodsFrom October 2013 to December 2018, pregnant women in their third trimester were recruited in two primary health centers (one suburban, one rural) in Senegal. Healthcare workers interviewed women and collected a lower vaginal swab and a blood sample. Vaginal flora were classified into four categories using vaginal smear microscopic examination and Gram’s coloration. In our study, BV was defined as vaginal flora with no Lactobacillus spp. Variables associated with BV were analyzed using STATA® through univariate and multivariate analysis.ResultsA total of 457 women provided a vaginal sample for analysis. Overall, BV prevalence was 18.6% (85/457) [95% CI 15.4–22.6]) and was similar in suburban and rural areas (18.9% versus 18.1%, p = 0.843). Multivariate analysis showed that primigravidity was the only factor independently associated with a lower risk of BV (aOR 0.35 [95% CI 0.17–0.72]).ConclusionsOur study showed significant BV prevalence among pregnant women in Senegal. Although the literature has underscored the potential consequences of BV for obstetric outcomes, data are scarce on BV prevalence in sub-Saharan African countries. Before authorities consider systematic BV screening for pregnant women, a larger study would be useful in documenting prevalence, risk factors and the impact of BV on pregnancy outcomes.

Astodrimer gel for treatment of bacterial vaginosis: A systematic review and meta-analysis of randomized controlled trials.

Bacterial vaginosis is a frequent source of vaginal infection among reproductive-aged women. Astodrimer gel is a novel drug which demonstrated favourable outcomes for treatment of patients with bacterial vaginosis. We attempted to conduct a systematic review and meta-analysis of all randomized controlled trials (RCTs) which examined the efficacy and safety of astodrimer gel in patients with bacterial vaginosis. We searched four databases from inception to August 15, 2020, using relevant keywords. We identified all RCTs which surveyed the efficacy and safety of astodrimer gel in treating patients with bacterial vaginosis. We appraised the quality of the included RCTs using the Cochrane risk of bias assessment tool. We pooled dichotomous outcomes as numbers and totals and reported them as risk ratios (RR) with 95% confidence intervals (95% CI) under random- or fixed-effects meta-analysis models depending on heterogeneity. Three eligible studies comprising four independent RCTs and 1165 patients were identified (614 and 551 patients received astodrimer gel and placebo, respectively). For efficacy outcomes (n=320 astodrimer gel versus n=260 placebo), astodrimer gel was significantly superior to placebo for all pooled efficacy outcomes, including clinical cure rate (at 9-12 and 21-30days), microbiological Nugent cure rate (at 9-12 and 21-30days), patient self-reported absence of vaginal odor/discharge (at 9-12 and 21-30days), resolution of Amsel criteria (at 9-12days) and percentage of patients who did not receive rescue therapy during study. With respect to safety outcomes (n=614 astodrimer gel versus n=551 placebo), astodrimer gel demonstrated equal tolerability to placebo for all pooled safety endpoints, expect unfavourably for vulvovaginal candidiasis and treatment-related vulvovaginal candidiasis. Astodrimer gel is effective in treating bacterial vaginosis and corroborated by clinical (Amsel criteria) and microbiological (Nugent score) measurements as well as patient-reported symptoms. Moreover, astodrimer gel is largely safe and associated with marginal rate of vulvovaginal candidiasis.

A novel non-antimicrobial treatment of bacterial vaginosis: An open label two-private centre study

BackgroundBacterial vaginosis (BV) is the most common cause of vaginal discharge. It is caused by an imbalance in the normal vaginal microbiota. Symptoms include an offensive odour. Standard oral or vaginal antimicrobial treatments have high immediate cure rates but almost as high recurrence rates. pHyph, a vaginal pessary, contains glucono-delta-lactone (GDL) and sodium gluconate (NaG) which restore normal pH and disrupt the associated biofilm. AimTo investigate the clinical performance of pHyph, for both treatment and recurrence prevention. Design An open-label, single arm, multi-centre first in women study. SettingTwo private gynaecology clinics in Skåne County, Southern Sweden. MethodsTwenty four adult women with confirmed bacterial vaginosis received the investigational product for self-administration on days 0, 2, 4, and 6 and were assessed on day 7. Clinical cure was defined as absence of three of four Amsel’s criteria (pH excluded) on day 7. Safety and tolerability were also recorded. Those not cured by day 7 received a prolonged treatment protocol. Results There were three withdrawals, two before the day 7 assessment. 18/22 (82 %) were clinically cured at day 7. The pessary was well tolerated. Recurrence rates at 14 days in patients cured at day 7 after receiving standard study treatment (n = 18) were 1/18 (5.6 %) with no additional recurrences reported at 35 days. Three of four patients not cured at 7 days received continued treatment (day 7, 9, 11, and 13), but none were cured at 14 days. ConclusionpHyph has the potential for both high cure rates and a reduction in recurrence.

Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

BackgroundBacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care.MethodsStepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4–10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4–10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks.DiscussionCurrent treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence.Trial registrationThe trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111–1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true).

Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis

Abstract Background Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests ...

Evaluation of different culture media to support in vitro growth and biofilm formation of bacterial vaginosis-associated anaerobes.

BackgroundBacterial vaginosis (BV) is one of the most common vaginal infections worldwide. It is associated with the presence of a dense polymicrobial biofilm on the vaginal epithelium, formed mainly by Gardnerella species. The biofilm also contains other anaerobic species, but little is known about their role in BV development.AimTo evaluate the influence of different culture media on the planktonic and biofilm growth of six cultivable anaerobes frequently associated with BV, namely Gardnerella sp., Atopobium vaginae, Lactobacillus iners, Mobiluncus curtisii, Peptostreptococcus anaerobius and Prevotella bivia.MethodsA total of nine different culture media compositions, including commercially available and chemically defined media simulating genital tract secretions, were tested in this study. Planktonic cultures and biofilms were grown under anaerobic conditions (10% carbon dioxide, 10% helium and 80% nitrogen). Planktonic growth was assessed by optical density measurements, and biofilm formation was quantified by crystal violet staining.ResultsSignificant planktonic growth was observed for Gardnerella sp., A. vaginae and L. iners in New York City III broth, with or without ascorbic acid supplementation. Biofilm quantification showed high in vitro biofilm growth for Gardnerella sp., P. anaerobius and P. bivia in almost all culture media excluding Brucella broth. Contrary, only New York City III broth was able to promote biofilm formation for A. vaginae, L. iners and M. curtisii.ConclusionsOur data demonstrate that New York City III broth relative to the other tested media is the most conducive for future studies addressing polymicrobial biofilms development as this culture medium allowed the formation of significant levels of single-species biofilms.

Testing the regulatory framework in South Africa \u2013 a single-blind randomized pilot trial of commercial probiotic supplementation to standard therapy in women with bacterial vaginosis

BackgroundBacterial vaginosis (BV) increases HIV risk and adverse reproductive outcomes. Standard-of-care (SOC) for BV are antibiotics; however, cure rates are low. Probiotics for vaginal health may be useful in improving cure and recurrence although the regulatory framework governing probiotics and the conduct of randomized clinical trials to evaluate these has not been established in South Africa. We performed an exploratory single-blind trial evaluating a commercial oral-vaginal-combination probiotic as adjunct to SOC for BV treatment.MethodsWomen with symptomatic vaginal discharge were screened for BV and common sexually transmitted infections (STIs). BV+ (Nugent 7–10) but STI- women were randomized to vaginal metronidazole alone (n = 12) or to metronidazole followed by a commercial oral/vaginal probiotic (n = 18). The primary qualitative outcome was to test the regulatory landscape for conducting randomized probiotic trials in South Africa; and acceptability of vaginal application by women. BV cure at 1 month (Nugent≤3) was the primary quantitative endpoint. Secondary quantitative endpoints were BV recurrence, symptoms, vaginal microbiota and genital cytokine changes over 5 months post-treatment.ResultsThe South African Health Products Regulatory Authority (SAHPRA) reviewed and approved this trial. As probiotics continue to be regulated as health supplements in South Africa, SAHPRA required a notification application for this trial. Acceptability and adherence to the oral and vaginal application of the probiotic were high, although women reported a preference for oral capsules. 44.8% of women cleared BV one-month post-treatment, and no significant differences in BV cure (RR = 0.52, 95% CI = 0.24–1.16), recurrence, vaginal pH, symptoms, microbiota or vaginal IL-1α concentrations were found between SOC and intervention groups in this pilot study with an over-the-counter product.ConclusionNavigation of the SAHPRA registration process for evaluating a commercial probiotic in a randomised trial laid the foundation for planned larger trials of improved probiotic products for vaginal health in South Africa. Although adherence to the vaginally delivered probiotic was high, women preferred oral application and we recommend that improvements in the content and method of application for future probiotics for vaginal health should be considered.Trial registrationThis trial was registered on 17 October 2017 with the South African National Clinical Trial Register (http://www.sanctr.gov.za/; BV-trial1; DOH-27-1117-5579).