Nugent Score Research Articles

P-2159. Potential Application of a Clinical-Grade Next Generation Sequencing Assay for Detection of Bacterial Vaginosis Associated Organisms in Urine

Abstract Background Bacterial vaginosis (BV) is the most common cause of vaginal dysbiosis in women affecting about 21.2 million women ages 14-49 in the United States. Vaginal swabs are typically used for BV diagnosis using a combination of microscopy and PCR tests. Timely and precise diagnostics is essential for enhancing patient outcomes and minimizing antibiotic prescription. However, limitations persist within thediagnostic approaches currently employed in clinical practice. BIOTIA-ID Urine NGS Assay was assessed as a tool to diagnose BV from urine by developing an (NGS)-based Nugent score based on compositional dynamics of lactobacilli and BV-associated organisms. Methods Healthy donor (HD, n=20) and culture negative (CN, < 100k CFU/mL) urine specimens (n=201) were collected from patients with pyuria and UTI symptoms and processed with the BIOTIA-ID Urine NGS Assay including DNA extraction, library preparation, Illumina-NextSeq sequencing and BIOTIA-DX analysis to identify urogenital pathogen infections. Findings were correlated with clinical metadata (Advarra Pro00038083, IRBNet 1950413-1). Results BIOTIA-ID yielded an average of 2.15M microbial reads per sample with 100% passing laboratory QC and classified 62% of the CN-specimens as positive for dysbiosis/infection while HD specimens were negative. Gardnerella vaginalis (21.4%), Prevotella (14.9%), and Aerococcus species (6.9%) were the most often detected organisms in NGS-positive samples while 70% of HD were predominantly Lactobacillus species. 65% of the Gardnerella positive specimens were symptomatic women of reproductive age (18-49 age group) and 29.3% took a course of antibiotics 30 days prior to urine collection. Development and evaluation of an NGS-based Nugent score revealed significantly higher scores in the urine of BIOTIA-ID Gardnerella positive specimens (p< 0.0001). Conclusion Similar to PCR studies, here we demonstrate that a urine specimen, which is noninvasive, and the incorporation of an NGS-Nugent score has potential application for BV diagnostics. Prospective clinical utilization studies in which collection of vaginal swabs and urine from both HD and clinically BV-positive patients are warranted to further develop and validate BIOTIA-ID as a BV-diagnostic assay. Disclosures Mara Couto-Rodriguez, MS, Biotia: Employee|Biotia: Stocks/Bonds (Private Company)|Biotia Inc: Employee|Biotia Inc: Stocks/Bonds (Private Company) Sol Rey, BS, Biotia: Employee|Biotia: Stocks/Bonds (Private Company) Heather L. Wells, MPH, PhD Candidate, Biotia, Inc.: Employee Tiara Rivera, B.S., Biotia: Employee|Biotia: Stocks/Bonds (Private Company) Xavier O. Jirau Serrano, MS, Biotia Inc: Employee|Biotia Inc: Stocks/Bonds (Private Company) John C. Papciak, BS, Biotia: Employee|Biotia: Stocks/Bonds (Private Company) David C. Danko, Ph.D., Biotia Inc: Employee|Biotia Inc: Stocks/Bonds (Private Company) Christopher E. Mason, PhD, Biotia: Board Member|Biotia: Honoraria|Biotia: Ownership Interest|Biotia: Stocks/Bonds (Private Company) Niamh B. O'Hara, PhD, Biotia: Board Member|Biotia: Two patents related to genomic sequence analysis of microbial species|Biotia: Ownership Interest|Biotia: Stocks/Bonds (Private Company) Dorottya Nagy-Szakal, MD PhD, Biotia Inc: Employee|Biotia Inc: Stocks/Bonds (Private Company)

Association between changes in genital immune markers and vaginal microbiome transitions in bacterial vaginosis

Bacterial vaginosis (BV), characterized by an imbalance in the vaginal microbiota, is a prevalent condition among women of reproductive age and a risk factor for human immunodeficiency virus, sexually transmitted infections, and preterm birth. BV is generally considered to induce mucosal inflammation, but the specific pathways and cell types involved are not well characterized. This prospective study aimed to assess associations between microbial changes and mucosal immune responses in BV patients. Therefore, samples from 20 premenopausal women with BV and treated with metronidazole were analyzed. Vaginal swabs, menstrual cup, and endocervical cytobrush samples were collected before treatment, weekly for four weeks, and at 2, 4, and 6 months for Nugent scoring, immune cell populations and cytokine analysis. Of 105 study intervals, 27 (25.7%) showed improvement in Nugent category, 61 (58.1%) remained unchanged, and 17 (16.2%) worsened. Improvement correlated with decreased monocytes (p = 0.005), while worsening was linked to increased monocytes (p < 0.001) and dendritic cells (p = 0.02). B cells (p = 0.02) and IFN-γ-induced chemokines - IP-10 (p = 0.007), MIG (p = 0.049), and ITAC (p = 0.005) - were associated with improvement. In conclusion, although the T-cell-associated chemokines IP-10, ITAC, and MIG were strongly associated with improvements in Nugent category, our findings indicate that antigen-presenting cells, particularly monocytes, show the most dynamic response to shifts in the vaginal microbiota in patients with BV.

Jiawei Ermiao Granules (JWEMGs) clear persistent HR-HPV infection though improving vaginal microecology.

Jiawei Ermiao Granules (JWEMGs), a traditional Chinese herbal formulation, has been widely used in China for the treatment of human papillomavirus (HPV) infections. However, the underlying mechanisms through which it exerts its antiviral effects remain poorly understood. This study aimed to investigate the potential mechanisms by which JWEMGs modulate vaginal microecology and clear HPV infections, utilizing clinical trials, metagenomic sequencing, and in vitro models. Clinical indicators related to vaginal microecology, such as vaginal pH, cleanliness, Nugent score, Donders score, catalase, neuraminidase, and leukocyte esterase, were evaluated in 65 patients with high-risk HPV (HR-HPV) infection. The study examined the impact of two courses of oral JWEMGs on these clinical parameters. Additionally, metagenomic sequencing was performed on vaginal lavage samples from 33 patients to assess the alteration of the vaginal microbiome following JWEMGs treatment. Immunohistochemistry was used to detect ALPK1 expression in cervical exfoliated cells, and ELISA was employed to measure cytokine levels in vaginal lavage fluid. JWEMGs intervention was applied to HaCaT-HPV E6/E7 cells to evaluate its effects on restoring α-kinase 1 (ALPK1) expression and promoting the secretion of cytokines and chemokines. Treatment with JWEMGs significantly improved several clinical indicators, including cleanliness, pH, Nugent score, Donders score, catalase, neuraminidase, and leukocyte esterase, in HR-HPV-infected patients. Furthermore, JWEMGs therapy led to an increased abundance of Lactobacillus species, especially Lactobacillus crispatus, and a marked reduction in Gardnerella species. JWEMGs treatment also significantly promoted ALPK1 expression in cervical exfoliated cells and augmented the secretion of key cytokines, including IL-6, IL-8, and TNF-α. In parallel, in vitro results showed that JWEMGs substantially enhanced IL-6, IL-8, TNF-α, CCL2, CCL5, and CCL7 secretion in HaCaT-HPV E6/E7 cells, which correlated with the activation of the ALPK1/NF-κB signaling pathway. In conclusion, JWEMGs treatment effectively remodels the vaginal microbiota and bolsters mucosal immunity in the lower genital tract, thereby improving the vaginal microecology in HR-HPV-infected individuals. In vitro findings further demonstrated that JWEMGs promote cytokine and chemokine expression, activating the ALPK1/NF-κB pathway.

COMPARISON OF FREQUENCY OF SUCCESSFUL TREATMENT IN PATIENTS OF BACTERIAL VAGINOSIS TREATED WITH INTRAVAGINAL METRONIDAZOLE VERSUS INTRAVAGINAL PROBIOTICS

Background: Bacterial vaginosis (BV) is a prevalent vaginal infection caused by an imbalance of lactobacillus-dominated flora and overgrowth of anaerobic bacteria such as Gardnerella vaginalis and Mycoplasma hominis. Standard treatment with intravaginal metronidazole often faces limitations such as recurrence, adverse effects, and poor compliance. Probiotics have emerged as a potential alternative by restoring vaginal microbiota without significant side effects. This study aimed to compare the efficacy of intravaginal probiotics and metronidazole for treating bacterial vaginosis. Objective: To compare the frequency of successful treatment in patients with bacterial vaginosis treated with intravaginal metronidazole versus intravaginal probiotics. Methods: This randomized controlled study was conducted over six months at the Department of Obstetrics &amp; Gynecology, Sandeman Provincial Hospital, Quetta. A total of 66 women aged 18-35 years with BV (Nugent score ≥7) were randomly allocated into two groups. The BV-P group received intravaginal probiotics, while the BV-M group received intravaginal metronidazole. Treatment success was defined as the resolution of fishy odor and a Nugent score &lt;4 at 30 days post-treatment. Baseline characteristics, follow-up Nugent scores, and treatment outcomes were recorded and analyzed using SPSS version 20.0. Results: Participants had a mean age of 27.2 ± 5.3 years, with 37.9% aged 18-25 years and 62.1% aged 26-35 years. The mean disease duration was 12.8 ± 4.2 days. At baseline, both groups were comparable in age, disease duration, and Nugent scores (p &gt; 0.05). At follow-up, the probiotics group demonstrated a significantly lower Nugent score (2.24 ± 1.50 vs. 3.79 ± 2.52, p = 0.004) and a higher success rate (90.9% vs. 60.6%, p = 0.004). Probiotics maintained superior outcomes across all subgroups. Conclusion: Intravaginal probiotics showed significantly better efficacy than metronidazole in treating bacterial vaginosis, with improved Nugent scores and treatment success rates. Probiotics represent a viable alternative to traditional antibiotic therapy, providing better patient outcomes with minimal side effects.

Efficacy of Oral Probiotic Supplementation in Preventing Vulvovaginal Infections During Pregnancy: A Randomized and Placebo-Controlled Clinical Trial.

This study aimed to investigate the efficacy of oral probiotic supplementation in preventing vulvovaginal infections (VVIs) in pregnant women, specifically focusing on abnormal vaginal flora (AVF), bacterial vaginosis (BV), and vulvovaginal candidiasis (VVC). A multicenter-prospective-randomized, double-blind, placebo-controlled trial was conducted during 2016-2019. Women with normal vaginal flora (Nugent score < 4 and no candida) were divided into a research group, receiving 2 capsules/day of oral probiotic formula containing Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus, Lacticaseibacillus paracasei, Lacticaseibacillus rhamnosus, and Streptococcus thermophilus, or a control group, receiving a placebo until delivery. Once a month and following complaints, a vaginal smear was taken to assess vaginal flora. Vaginal colonization with the specific lactobacilli from the probiotic capsules was detected using the matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. The primary outcome was the rate of women who developed VVI. Forty-nine and fifty-one women were analyzed in the probiotic and placebo cohorts, respectively. There was no difference in the rate of VVI between probiotic and placebo groups (14 (29%) versus 14 (27%), respectively; p = 0.80). No woman had vaginal colonization with lactobacilli from the probiotic capsule. The tested oral probiotic product did not reduce the rate of VVI in pregnant women with normal vaginal flora.

Differences in HIV risk factors between South African adolescents and adult women and their association with sexually transmitted infections

ObjectivesIn sub-Saharan Africa, approximately 86% of HIV infections in adolescents aged 15–19 years occur among girls. Their heightened susceptibility is likely influenced by converging sociobehavioural and biological factors, although the...

Performance of deep learning models in predicting the nugent score to diagnose bacterial vaginosis.

The Nugent score is a commonly used diagnostic tool for bacterial vaginosis. However, its accuracy depends on the skills of laboratory technicians. This study aimed to evaluate the performance of deep learning models in predicting the Nugent score to improve diagnostic consistency and accuracy. In total, 1,510 vaginal smear images collected from a hospital in Japan between 2021 and 2023 were assessed. Each image was annotated by laboratory technicians into one of four categories based on the Nugent score-normal vaginal flora, no vaginal flora, altered vaginal flora, or bacterial vaginosis. Deep learning models were developed to predict these categories, and their performance was compared to that of technician annotations. The deep learning models demonstrated 84% accuracy at 400× magnification and 89% at 1,000× magnification. The 1,000× model was further optimized and tested on an independent set of 106 images. After optimization, the advanced model achieved 94% accuracy, outperforming the average 92% accuracy of the technicians. The agreement between the advanced model predictions and technicians was 92% for normal vaginal flora, 100% for no vaginal flora, 91% for altered vaginal flora, and 100% for bacterial vaginosis. Overall, our findings suggest that deep learning models have the potential to diagnose bacterial vaginosis with an accuracy comparable to that of laboratory technicians.IMPORTANCEBacterial vaginosis is a global health issue affecting women, causing symptoms such as abnormal vaginal discharge and discomfort. The Nugent score is a standard method for diagnosing bacterial vaginosis and is based on the manual interpretation of Gram-stained vaginal smears. However, this method relies on the skill and experience of trained professionals, leading to variability in results and poses significant challenges for settings with limited access to experienced technicians. The results of this study indicate that deep learning models can predict the Nugent score with high accuracy, offering the potential to standardize the diagnosis of bacterial vaginosis. By reducing observer variability, these models can facilitate reliable diagnoses, even in settings where experienced personnel are scarce. Although validation is needed on a larger scale, our results suggest that deep learning models may represent a new approach for diagnosing bacterial vaginosis.

Evaluation of the Vaginal Panel Realtime PCR kit (Vircell, SL) for diagnosing vaginitis: A comparative study with routinely used diagnostics.

Vaginitis is a prevalent clinical disorder associated with several adverse health consequences, prompting women to seek medical care. In this study we evaluate the Vaginal Panel Real-Time PCR kit (qPCR test) against routinely used diagnostics for detection of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis. A total of 1011 vaginal swab specimens were analyzed. The routinely diagnostic methods for BV was Gram stain-based Nugent score. VVC presence was detected by culture, and Candida species were identified using MALDI-TOF MS. Trichomonas vaginalis was identified by culture in a selective medium. Molecular analyses were conducted on the MagXtract® 3200 System and analyzed using the CFX96™ Real-Time PCR Detection System. The sensitivity, specificity, positive predictive value, and negative predictive value of the qPCR test compared to the reference method for BV diagnosis was 93.1%, 88.8%, 90.1% and 92.2%, respectively, with a Kappa value of 0.82. For Candida species, sensitivity, specificity, positive predictive value, and negative predictive value were 96.0%, 98.4%, 95.3%, and 98.7%, respectively. The qPCR test detected 32 additional positive samples for Candida not reported by the routinely used diagnostics. For trichomoniasis, the qPCR test identified T. vaginalis in fifteen specimens, despite no microscopic detection in cultured specimens. Our results demonstrate that the Vaginal Panel Real-Time PCR kit shows optimal concordance with routinely used diagnostics for diagnosing vaginitis. Furthermore, enhancing detection of T. vaginalis. However, further validation studies are necessary to confirm its full diagnostic accuracy. The use of nucleic acid amplification tests (NAATs) provides rapid and accurate diagnosis, crucial for early detection and treatment of vaginitis.

Use of an Ethinyl Estradiol/Etonogestrel Vaginal Ring Alters Vaginal Microbial Communities in Women with HIV.

HIV-1 antiretroviral therapy (ART) alters hormonal contraceptive levels delivered via intravaginal ring (IVR) in a regimen specific manner. We explored the role of the IVR on vaginal microbial communities, vaginal short chain fatty acids (SCFAs), vaginal HIV shedding, and the effect of vaginal microbes on hormone concentrations in cisgender women with HIV (WWH). Vaginal microbes were assessed by 16S RNA sequencing of weekly vaginal swabs, vaginal SCFA by mass spectrometry, HIV-1 shedding by nucleic acid amplification on vaginal aspirates, and bacterial vaginosis by Nugent scoring from 74 participants receiving an etonorgestrel/ethinyl estradiol (ENG/EE) intravaginal ring while on no ART (N=25), efavirenz-based ART (N=25), or atazanavir-based ART (N=24). At baseline, microbial communities of the 64 substudy eligible participants robustly classified as Lactobacillus crispatus--dominant (n=8), L. gasseri-dominant (n=2), L. iners-dominant (n=17), or mixed anaerobic communities (n=37). During IVR therapy, there was an increased probability of Lactobacillus-dominant community state types (CSTs) (odds-ratio=1.61, p=0.04). Vaginal CSTs were associated with Nugent scores. Bacterial vaginosis-associated bacteria were associated with significantly higher and L. iners with lower Nugent Scores (all p adj <0.1). Lactic acid levels were correlated with the relative abundance of Lactobacillus species (r2=0.574; p<0.001). Vaginal shedding of HIV-1 was less common in women with L. crispatus-dominant microbiomes (p=0.04). Mixed anaerobic vaginal communities modulated EE concentrations in a regimen-specific manner. Combined ENG/EE IVR therapy was associated with an increase in Lactobacillus-dominant vaginal microbial communities in WWH and may benefit those with bacterial vaginosis. EE levels were altered by the vaginal microbiota.

Comparative efficacy of oral and vaginal probiotics in reducing the recurrence of bacterial vaginosis: a double-blind clinical trial

ObjectiveThe primary goal of this study is to discern the optimal adjuvant treatment for patients diagnosed with bacterial vaginosis, focusing on reducing recurrence rates.MethodsThis study is a double-blind clinical trial with no previous similar trials conducted to date. The study population consisted of non-pregnant, married women visiting teaching hospitals’ clinics in Mashhad, complaining of vaginal discharge. After informed consent and questionnaire completion, samples were obtained from vaginal discharge surrounding the cervix of clinically diagnosed bacterial vaginosis patients. Using Gram staining, a gold standard method for bacterial vaginosis diagnosis, samples were examined under a microscope according to the Nugent score. After initial treatment with metronidazole, patients were divided into two groups receiving either vaginal or oral probiotics.ResultsOf the 55 participating women, 20 were in the vaginal probiotic group and 35 were in the oral probiotic group. No significant demographic or clinical differences existed between groups at baseline. The Nugent score decreased from 8.5 to 3 in the vaginal group and from 9 to 3 in the oral group, suggesting the effectiveness of both treatments. While the difference between groups was not statistically significant, each group showed significant improvements from their initial states (p-value < 0.001).ConclusionNo significant difference was observed in the effectiveness of oral versus vaginal probiotics in reducing the recurrence of bacterial vaginosis after routine treatment. Therefore, the type of probiotic to be used could be chosen based on patient preference.

A New Real-Time PCR Test (Flora Select™) and Nugent Score for the Diagnosis of Bacterial Vaginosis During Pregnancy.

This prospective cohort study aimed to evaluate the performance of Flora select™ (FS), a newly developed real-time PCR test, for the assessment of the vaginal microbiome during early pregnancy. Five hundred and fifty-six pregnant women underwent examinations of FS, Nugent score-a Gram-staining scoring system for the diagnosis of bacterial vaginosis (BV)-and conventional bacterial culture between 8 weeks and 12 gestational weeks. Nugent scores of 0-3, 4-6, and ≥7 were found in 469 (84.2%), 41 (7.4%), and 47 (8.5%) of the women, respectively. Relative dominance rates of Lactobacillus species of high (≥80% medium (50%≤, <80%), and low (0.1≤, <50%), and no detection (<0.1%) were 63.0%, 8.8%, 17.1%, and 11.2%, respectively. Gardnerella, Prevotella, Atopobium, Streptococcus, Ureaplasma, and Mycoplasma species were detected in 23.9%, 17.6%, 17.1%, 7.0%, 23.0%, and 4.9% of the women, respectively. Gardnerella species were detected in all women with Nugent scores ≥7 and Ureaplasma were detected in 40.4% of them. BV-associated bacterial species were also detected in 70.7% of women with Nugent scores of 4-6. Gardnerella, Prevotella, Atopobium, Streptococcus, Ureaplasma, and Mycoplasma species were highly prevalent in women with Nugent scores ≥4 or Lactobacillus species <50%. FS detected Gardnerella, Prevotella, and Atopobium species more effectively than conventional bacterial culture. FS could determine relative dominance rates of Lactobacillus species in the vaginal microbiome, and simultaneously detect four kinds of BV-associated bacteria, Ureaplasma and Mycoplasma species. Therefore, FS may be clinically useful for the screening of the vaginal microbiome during pregnancy to prevent preterm birth and for the assessment of the vaginal microbiome after BV treatments.

Clinical Validation and Comparison of Bacterial Vaginosis Detection

Abstract Introduction/Objective Bacterial vaginosis (BV) is considered a top reason for women’s gynecological visits, causing symptoms such as vaginal discharge, foul odor, itching, and burning associated with the alteration of the normal vaginal microbiome. It is often presented as a decrease in Lactobacillus spp. and an increase in anaerobic organisms such as Gardnerella vaginalis and Atopobium vaginae. In response to the demand for more automated and less subjective testing, molecular methods have recently been developed to aid in BV testing. The objectives of this study are to validate and compare the molecular Aptima® Bacterial Vaginosis Assay by Hologic® to the established BV Screen via a Gram stained vaginal smear graded through Nugent scoring at RUSH University Medical Center in Chicago, IL and perform a cost analysis between the testing methods. Methods/Case Report Samples of known BV value were tested on the Panther® instrument to validate the Aptima® Bacterial Vaginosis Assay for accuracy and precision. Clinical samples of vaginal swabs were used to make a Gram stained BV screen for Nugent scoring, then afterwards were placed into Hologic Multitest Aptima® probes for molecular testing on the Panther® instrument. Nugent scoring was performed blind by the molecular test. Molecular results of negative, positive, and invalid were then compared to the Nugent scores: scores of 0-3 for negative/normal vaginal flora, 7-10 for positive BV, and 4-6 for intermediate/altered scores were screened for discrepancy. Results (if a Case Study enter NA) The Aptima® BV Assay tested 52 known samples with 97% accuracy and 100% precision. A total of 80 clinical samples of vaginal swabs used for Gram stained BV screens were run on the Aptima® BV Assay; 61 provided conclusive data for comparative analysis. When compared to the original Nugent scores, the positive percent agreement (PPA) was 77.0% and negative percent agreement (NPA) was 92.9%. Conclusion The Aptima® BV Assay proved to be both accurate and precise in its validation testing. Clinically, it was able to screen for BV in vaginal samples with a good percent agreement to Gram stained BV screens. Further testing of additional clinical samples are to be done to continue analysis. Although the supplies needed to perform a Gram stain cost less than molecular testing, the reimbursement payment for molecular testing is much greater and overall reduces employee time costs for performing the test, making it the more cost effective choice for the laboratory.

A Multi-Strain Oral Probiotic Improves the Balance of the Vaginal Microbiota in Women with Asymptomatic Bacterial Vaginosis: Preliminary Evidence

Background/Objectives: the vaginal microbiota is known to confer protection in the genital ecosystem, due to the predominance of different Lactobacillus species, playing a crucial role in women’s health; alterations in the composition of the microbial communities in the vagina can be associated with the development of bacterial vaginosis (BV). Current therapy for BV involves oral or intravaginal administration of metronidazole or clindamycin, albeit the high recurrence rates suggest a need for alternative therapeutic tools, such as probiotics. Herein, the diversity and composition of vaginal microbiota in women with asymptomatic BV was investigated before and after the oral administration of a multi-strain probiotic formulation. Methods: a prospective observational pilot study with pre–post design was carried out from 1 June 2022, to 31 December 2022, on reproductive-age women with asymptomatic BV, as diagnosed via Nugent score, and matched healthy controls. The probiotic was administered to all study participants as acid-resistant oral capsules (twice daily), and a vaginal swab was collected at baseline and after 2 months of treatment, for the metagenomic analysis of 16s rDNA. Results: the diversity and richness of the vaginal microbiota in women with BV were significantly reduced after 2 months of supplementation with the oral probiotic, as evidenced by measures of α-diversity. Interestingly, some bacterial genera typically associated with dysbiosis, such as Megasphaera spp., were significantly decreased; whereas, at the same time, Lactobacillus spp. Doubled. Conclusions: our preliminary results suggest that the multi-strain oral probiotic is a beneficial treatment specifically targeting the dysbiotic vaginal microenvironment.

The vaginal microbiome of transgender men receiving gender-affirming hormonal therapy in comparison to that of cisgender women

The vaginal microbiome of trans men and menopausal women is suspected to be similar due to a lack of estrogen leading to the absence of lactobacilli. However, data are scarce. We performed an analysis of the vaginal microbiome of trans men (n = 25) in comparison to that of menopausal (n = 25) and premenopausal women (n = 25). The vaginal microbiome of trans men and menopausal women showed a higher alpha diversity than that of premenopausal women. Various beta diversity indices (e.g., Bray‒Curtis (Un-)Weigthed Unifrac), showed significant differences in community composition between trans men and premenopausal (p < 0.001) and menopausal women (p < 0.001). The vaginal microbiome of trans men is characterized by a loss of Lactobacillus and an increase in bacteria associated with the intestinal flora (e.g., Campylobacter, Anaerococcus, Dialister, Prevotella). The abundance of Dialister and Prevotella decreased with the length of hormonal therapy in trans men. The Nugent score, Pap smear and HPV status did not differ between the study groups. The vaginal microbiome of trans men differs from that of premenopausal women but shows similarities to that of menopausal women. The duration of hormonal therapy in trans men may have important impacts on the vaginal microbiome and thus possibly on the risk for STIs.

Prevalence of bacterial vaginosis and its associated factors among pregnant women attending antenatal care clinics at public hospitals in West Shoa Zone, Oromia, Ethiopia

Bacterial vaginosis is a polymicrobial syndrome characterized by the decrease of Lactobacilli and an overgrowth of facultative and anaerobic bacteria in vaginal fluid. Though it has received little attention, it has been associated with poor pregnancy outcomes, such as pre-term labor and delivery, premature rupture of membranes, low birth weight, spontaneous abortion, and postpartum infections. This study aimed to determine the prevalence of bacterial vaginosis and its associated factors among pregnant women attending antenatal care clinics from September 15 to December 14, 2021, at public hospitals in West Shoa Zone, Oromia, Ethiopia. An institutional-based cross-sectional study was conducted on 260 pregnant women, and systematic random sampling was employed to recruit the study participants. Data were collected through a structured questionnaire and the vaginal swab was collected using a sterile cotton swab. The gram staining result was interpreted using the Nugent scoring system. Data was entered into an Excel spreadsheet and exported to STATA-14 for analysis. Data were presented using tables and graphs. Binary and multivariable logistic regressions were performed. Variables with a P value ≤ 0.25 at the binary logistic regression were entered into the multivariable logistic regression. Finally, variables with a P value ≤ 0.05 were considered predictors of bacterial vaginosis and interpreted using adjusted Odds Ratios (AOR) with a 95% confidence interval (CI). A total of 260 pregnant women attending antenatal care were included in the study. The prevalence of bacterial vaginosis according to the Nugent scoring system was 22.3% (95% CI 17.4 to 27.9%). Pregnant women with other marital status were at reduced risk of bacterial vaginosis as compared with married pregnant women (AOR = 0.260, 95% CI 0.068 to 0.9995; P = 0.05). Rural residence (AOR = 2.1, 95% CI 1.05 to 4.24; P = 0.036), use of one pant per week (AOR = 2.7, 95% CI 1.04 to 7.2; P = 0.041), and use of two or more pants per week (AOR = 4.96, 95% CI 1.49 to 16.57; P = 0.009) were significantly associated with bacterial vaginosis. In the current study, a high magnitude of bacterial vaginosis was reported. Residence, marital status, and number of pants used per week were found significantly associated among pregnant women. Hence, screening for the disease should be integrated into the recommended basic laboratory investigations during antenatal visits.

Prevention of Recurrent Spontaneous Preterm Delivery Using Probiotics (Clostridium butyricum, Enterococcus faecium, and Bacillus subtilis; PPP Trial): Protocol for a Prospective, Single-Arm, Nonblinded, Multicenter Trial.

The rate of recurrent spontaneous preterm delivery (sPTD) ranges between 27% and 34% and is 22.3% in Japan. Although it currently remains unclear whether probiotics prevent sPTD, retrospective studies recently reported a reduction in the rate of recurrent sPTD with the administration of probiotics including Clostridium spp., which induce regulatory T cells that play an important role in maintaining pregnancy. The objective of this trial is to evaluate the preventative effects of available oral probiotics, including Clostridium butyricum, on recurrent sPTD. This is a prospective, single-arm, nonblinded, multicenter trial in Japan. The sample size required for this trial is 345 pregnant women with a history of sPTD, considering a clinically significant reduction in the relative risk of 30% (risk ratio=0.7). The primary endpoint is the rate of recurrent sPTD at <37 weeks of gestation. The secondary endpoints are the rate of sPTD at <34 weeks of gestation, the rate of recurrent sPTD at <28 weeks of gestation, the ratio of intestinal Clostridium spp. (detected by next-generation sequencing), and bacterial vaginosis (using the Nugent score). The trial procedures were approved by the Clinical Research Review Board of Toyama University Hospital (SCR2020008) on March 31, 2021. The trial was registered on the Japan Registry of Clinical Trial website on April 28, 2021. Recruitment began on May 1, 2021, and the trial is estimated to finish on March 31, 2025. The findings will clarify the rate of recurrent sPTD following probiotic administration including Clostridium butyricum. Outcomes from this trial will inform clinical practice and guide future randomized controlled trials. Japan Registry of Clinical Trials jRCTs041210014; https://jrct.niph.go.jp/latest-detail/jRCTs041210014. DERR1-10.2196/59928.

Prevalence and risk factors of curable sexually transmitted and reproductive tract infections and malaria co-infection among pregnant women at antenatal care booking in Kenya, Malawi and Tanzania: a cross-sectional study of randomised controlled trial data

ObjectivesMalaria and curable sexually transmitted and reproductive tract infections (STIs/RTIs) are associated with adverse pregnancy outcomes. This study reports the prevalence and risk factors of curable STIs/RTIs, STI/RTI co-infection and...

Development of a Multiplex Real-Time Quantitative PCR Assay for Detecting Vaginal Microbiota in Chinese Women - China, 2021-2022.

The Nugent score, limited by subjectivity and personnel requirements, lacks accuracy. Establishing a precise and simple molecular test is therefore essential for detecting vaginal microbiota compositions and evaluating vaginal health. We evaluated the vaginal health of Chinese women using quantitative polymerase chain reaction (qPCR) to target Lactobacillus crispatus (L. crispatus), L. iners, Gardnerella vaginalis (G. vaginalis), Atopobium vaginae (A. vaginae), and Megasphaera phylotype1. bacterial vaginosis (BV)-related bacteria shared a fluorescent channel. Using 16S rDNA sequencing as a reference standard, we evaluated and validated the diagnostic accuracy of the qPCR assay. Both qPCR and 16S rDNA sequencing demonstrated 90.5% concordance in segregating vaginal community state type (CST), as visualized through heatmaps and PCoA. Spearman's correlation analysis revealed strong correlations between the two methods in calculating the RA of L. crispatus (CST I), L. iners (CST III), and BV-related bacteria (CST IV), with coefficients of 0.865, 0.837, and 0.827, respectively. Receiver operating characteristic analysis showed that qPCR had significant diagnostic accuracy for CST I, CST III, and CST IV (molecular BV), with area under the curve values of 0.967, 0.815, and 0.950, respectively, indicating strong predictive power. Vaginal health can be evaluated using a single qPCR amplification experiment, making the multiplex qPCR assay a highly accurate tool for this purpose.

Correlation between dysbiosis of vaginal microecology and endometriosis: A systematic review and meta-analysis.

Endometriosis, a complex gynecological condition, involves inflammation and immune dysregulation. The vaginal microbiota, characterized by its diversity, is an integral part of the vaginal microecology-interacting with vaginal anatomy, the endocrine system, and local mucosal immunity. Imbalances in this microecology are known to precipitate various inflammatory diseases. Despite extensive research, the connection between vaginal microbiota dysbiosis and endometriosis remains a subject of debate. Our study assesses the association between vaginal microecology dysbiosis and endometriosis. We systematically searched major electronic databases in English, including Embase, PubMed, The Cochrane Library, MEDLINE (Ovid), BIOSIS (Ovid), China National Knowledge Infrastructure (CNKI), and Wanfang, up to August 15, 2023. Selected articles underwent screening based on predefined inclusion and exclusion criteria. Normal vaginal microecology was defined as a negative Amsel/Spiegel test or Nugent score of 0-3, or Lactobacillus predominance determined by 16S rRNA gene amplification sequencing. Deviations from this norm were classified as dysbiosis, further categorized into bacterial vaginosis (BV) and intermediate BV. Data analysis utilized Revman 5.4, with effect sizes presented as Odds Ratios (OR) and 95% Confidence Intervals (CI). Out of 1081 articles, eight met the inclusion criteria. Utilizing fixed-effect models due to low heterogeneity, the analysis revealed a positive association between dysbiosis and endometriosis (OR = 1.17, 95% CI 0.81-1.70; I2 = 0%), but showed a slight negative association between normal vaginal microecology with endometriosis (OR = 0.90, 95% CI 0.55-1.46; I2 = 29%). However, the association was not significant. Subgroup and sensitivity analyses corroborated the stability of these associations. A positive correlation exists between vaginal microecology dysbiosis and endometriosis, notably with intermediate BV. However, the mechanisms underpinning this relationship remain elusive, highlighting the need for further research to overcome limitations. Registration number: CRD42023445163.

Prevalence and associated factors of bacterial vaginosis among pregnant women in Hue, Vietnam.

Bacterial vaginosis (BV) is the most frequent vaginal infection affecting women of childbearing age worldwide. It is associated with significant adverse healthcare outcomes, especially during pregnancy. Although screening for BV could reduce potential pregnancy-related obstetric complications, there is no routine screening of pregnant women for BV in Vietnam. We aimed to identify the prevalence of BV among pregnant women and the associated factors in two tertiary hospitals in Hue, Vietnam. This cross-sectional descriptive study included 885 pregnant women in third trimester, who received routine antenatal care in the Hue Central Hospital and Hue University Hospital of Medicine and Pharmacy, Hue city, Thua Thien Hue province, Vietnam. Gram-stained vaginal smears were used for calculating the Nugent score and recording the fungal elements. In total, 435 (49.1%) women had a normal BV score, 352 (39.8%) had intermediate vaginal microbiota, and 98 (11.1%) had BV. Among the 98 women with BV, 71 (72.4%) also had fungal infection. There was a significant association of BV with discharge (p = 0.004) and abnormal cervix (p = 0.014). BV was significantly more frequent among the women who reported previous abortion or miscarriage (p = 0.007). About a tenth of women in Thua Thien Hue province have BV in the third trimester of pregnancy being associated with previous adverse outcome. Discharge with fishy odour is still a characteristic feature among subtle clinical presentations of BV. Better awareness about this disease and routine test-and-treat management during pregnancy may improve pregnancy outcome.