Amsel Criteria Research Articles

Relationship between dietary inflammatory index, plant-based dietary index, and bacterial vaginosis: A case-control study.

Bacterial vaginosis (BV) is a common inflammatory condition affecting the vaginal microbiome. In the present study we aimed to explore the relationship between dietary inflammatory index, plant-based dietary index, and BV. In this case-control study, 143 individuals with BV and 151 healthy participants aged 15-45 years were included. Bacterial vaginosis diagnosis was based on the Amsel criteria by a gynecologist. Participants' dietary intakes over the past year were assessed using a 168-item food frequency questionnaire. Logistic regression models were employed to analyze the association between dietary inflammatory index, plant-based dietary index, and BV odds. Our study revealed that elevated dietary inflammatory index scores were strongly associated with higher BV odds in the crude model (odds ratio [OR]: 2.88, 95% confidence interval [CI]: 1.57-5.30, P value <0.001), and even after accounting for potential confounding factors (adjusted OR: 3.52, 95% CI: 1.66-7.46, P value = 0.001). While no significant relationship was observed between total plant-based dietary index and healthy plant-based dietary index scores with BV odds, a clear positive association existed between unhealthy plant-based dietary index and the odds of BV (aOR: 2.13, 95% CI: 1.09-4.15, P value = 0.018). A positive correlation may exist between unhealthy plant-based dietary index and the likelihood of BV. Furthermore, the dietary inflammatory index may remain linked to increased BV odds.

The association between dietary phytochemical index and bacterial vaginosis risk: secondary analysis of case-control study

IntroductionBy studying the dietary habits of patients with bacterial vaginosis (BV) and the controls, we aim to find out whether the dietary intakes of phytochemicals could reduce the odds of BV. To the best of our knowledge, no study has ever examined the matter before. Therefore, we decided to conduct this secondary analysis of case-control study to examine the association between dietary phytochemicals and BV.MethodThis case-control study was conducted at the gynecological clinic of Imam Hossein Hospital using a convenience sampling method from November 2020 to June 2021. To diagnose BV, all participants underwent examination by a gynecologist, assessing the presence of 3 or 4 criteria from the Amsel criteria. A validated semi-quantitative food frequency questionnaire was used. The phytochemical index was determined using McCarty’s method. To assess the association between dietary phytochemical intake and the odds of BV, binary logistic regression was utilized.ResultsAfter adjusting for potential confounders, the association between phytochemical index and BV remained significant (odds ratio (OR) = 0.349, 95% confidence interval (CI): 0.176–0.695, p-value = 0.003). Furthermore, each unit increase in fat intake was associated with higher odds of BV (OR = 1.008, 95% CI: 1.002–1.014, p-value = 0.006), and a positive family history of BV continued to show significantly increased odds of BV (OR = 3.442, 95% CI: 2.068–5.728, p-value < 0.001).ConclusionIn summary, the findings of this study indicate that increased consumption of dietary phytochemicals is associated with a reduced risk of BV among Iranian women of reproductive age. Additional research, especially longitudinal dietary studies, is required to explore the potential impact of dietary modifications on BV.

Amsel criteria based computer vision for diagnosing bacterial vaginosis

Bacterial vaginosis (BV) is a common vaginal infection that can predispose patients to several complications, such as pelvic inflammatory disease. Like many illnesses, existing diagnostic methods face a trade-off between diagnostic certainty and cost. To help address this dilemma, we explore a computational diagnostic approach implementable as an IoT device. We developed several deep learning models based on the Amsel criteria to evaluate different inexpensive point-of-care tests that better automate the diagnosis of BV. We first determined how to best diagnose BV via computer vision models trained on epithelial cell images. We found that training a ResNet18 model on NuSwab diagnostic labels achieved an 89% F1 score. We then experimented with augmenting computer vision results with other Amsel criteria values through multi-layer perceptrons, finding that also using whiff test values increased performance to an F1 of 91% and to a sensitivity surpassing human-performed Amsel criteria at 94.31%. These results provide the first insight into how combinations of images and other Amsel criteria data can best be used for reliable diagnoses, paving the way for future research into IoT-based BV diagnostics.

Determinants of Bacterial Vaginosis: A Retrospective Study

Background: Among women who can have children, bacterial vaginosis (BV) is the most common cause ofabnormal vaginal discharge. Due to its high prevalence and morbidity, it is crucial to prevent BV by addressing its risk factors. Objective: This study aimed to determine the incidence and determinants of BV in the sexually transmitted infection (STI) division of the Dermatovenereology Department at Dr. Soetomo Hospital in Surabaya. Methods: This retrospective analytical observational study was conducted using a cross-sectional approach. Electronic data from 56 patients were included in the study, covering the period from 2019 to 2022. The patients were divided into two groups: BV patients and controls. BV patients were diagnosed with BV by fulfilling three out of four Amsel criteria, while controls with typical vaginal discharge. Results: The study included 34 BV patients and 22 control patients. Bivariate analysis showed a significant correlation between the incidence of BV and the number of sexual partners (p = 0.009) and the use of intrauterine devices (IUD) (p = 0.002). Multivariate analysis confirmed that both factors were determinants of BV incidence, with IUD use being the most dominant determinant (95% CI 1.86~135.02, p = 0.01). Conclusion: The study found that the use of IUDs and the number of sexual partners significantly determined BV incidence.

Modern trends in the treatment of bacterial vaginosis in primigravida in the first half of gestation

Pregnancy with bacterial vaginosis (BV) is accompanied by a high risk of various obstetric and perinatal complications, including miscarriage, preterm birth, placental dysfunction, premature rupture of membranes, chorionamnionitis, polyhydramnios, etc. Screening for BV is carried out in the first half of pregnancy during the registration of a woman, however, taking into account the gestational age, many drugs with antimicrobial and antiseptic effects are categorically contraindicated, as they have an embryo- and fetotoxic effect.Timely detection and correction of microbiocenosis disorders of the birth canal is an extremely important element to prevent a number of obstetric and perinatal complications. A balanced approach in the treatment of vaginal dysbiosis consists in the use of modern combined antiseptic preparations for local treatment, which do not contain antibacterial components and are safe for use during pregnancy.The objective: to determine the effectiveness of the treatment of BV in primigravida women in the first half of pregnancy.Materials and methods. 126 primigravida women aged 18–35 years in the first half of pregnancy were examined during pregnancy registration. The participants were selected randomly.The main group included 36 primigravida women with a gestation period of up to 20 weeks with a diagnosis of BV according to the Amsel and Hay–Ison criteria, who were treated with a combined antiseptic drug (chlorhexidine and chlorophyllipt) – suppository vaginally twice a day, the course of treatment – 5 days. The control group included 30 primigravida women with a gestational age of up to 20 weeks with vaginal normocenosis.For all women the pH of vaginal secretions was determined, followed by microscopy of a native smear, stained according to Gram, and a cultural study was performed. Adherence to the Amsel criteria was also determined, followed by evaluation by the Hay–Ison criteria. The clinical effect was evaluated according to clinical examination data before and on the 6th day of treatment with a combined antiseptic drug (chlorhexidine and chlorophyllipt) using bacterioscopic and bacteriological methods.Results. A normal pH was observed only in every fifth part of examined pregnant woman (28 women – 22.2%), while in the rest patients the acidity of the vaginal environment was not normal. Normocenosis was observed only among 1/3 of primigravida women (37 women – 29.4%). A third of the patients were diagnosed with BV (36 women - 28.6%), every fifth pregnant woman – vulvovaginal candidiasis (28 women - 22.2%).In healthy pregnant women (control group, n=30), the main component of the microbiocenosis was Lactobacillus spp. with a small content of facultatively anaerobic microorganisms. In the main group Atopobium vaginae (38.9%), Gardnerella vaginalis (33.3%), Prevotella bivia (27.8%), Candida spp. (22.2%), as well as Lactobacillus spp. in low titers were dominated. Before the treatment all 36 pregnant women of the main group corresponded to the 3rd type according to the Hay–Ison criteria with the dominance of Gardnerella vaginalis and/or Mobiluncus morphotypes and a small number or complete absence of lactobacilli, which served as the basis for establishing the diagnosis of BV. After treatment type 1 (94.4%) was found in 34 pregnant women, and type 2 (5.6%) – in 2 pregnant women.The results of the microbiological study indicate the normalization of the content of the biotope with the predominance of Lactobacillus spp. in women of the main group, in whom the indicators were similar to the control group.Conclusions. Since pregnancy with BV is accompanied by a high risk of obstetric and perinatal complications, the premorbid background of which is laid already in the first half of pregnancy, there is an urgent need to carry out the birth canal sanitation. The drugs of choice for the BV in the first half of pregnancy are local combined agents of a wide spectrum of action.A universal antiseptic with an anti-inflammatory effect, which includes two components – chlorhexidine and chlorophyllipt, fully meets the recommendations for efficiency and safety and can be used for the BV in the first half of pregnancy.

Response to Antibiotic Treatment of Bacterial Vaginosis Predicts the Effectiveness of LACTIN-V (Lactobacillus crispatus CTV-05) in the Prevention of Recurrent Disease.

Live biotherapeutic products (LBPs) containing vaginal Lactobacillus crispatus are promising adjuvant treatments to prevent recurrent bacterial vaginosis (BV) but may depend on the success of initial antibiotic treatment. A post hoc analysis of data collected during the phase 2b LACTIN-V randomized control trial (L. crispatus CTV-05) explored the impact of clinical BV cure defined as Amsel criteria 0 of 3 (excluding pH, per 2019 Food and Drug Administration guidance) 2 days after completion of treatment with vaginal metronidazole gel on the effectiveness of an 11-week LACTIN-V dosing regimen to prevent BV recurrence by 12 and 24 weeks. At enrollment, 88% of participants had achieved postantibiotic clinical BV cure. The effect of LACTIN-V on BV recurrence compared with placebo differed by initial clinical BV cure status. The LACTIN-V to placebo risk ratio of BV recurrence by 12 weeks was 0.56 (95% confidence interval, 0.35-0.77) among participants with initial clinical BV cure after metronidazole treatment and 1.34 (95% confidence interval, 0.47-2.23) among participants without postantibiotic clinical BV cure. Among women receiving LACTIN-V, those who had achieved postantibiotic clinical BV cure at enrollment reached higher levels of detectable L. crispatus CTV-05 compared with women failing to achieve postantibiotic clinical BV cure. LACTIN-V seems to only decrease BV recurrence in women with clinical cure of BV after initial antibiotic treatment. Future trials of LBPs should consider limiting enrollment to these women.

Lacticaseibacillus rhamnosus TOM 22.8 (DSM 33500) is an effective strategy for managing vaginal dysbiosis, rising the lactobacilli population.

The present study is a single-centre, randomized, controlled clinical trial aimed to evaluate the effectiveness of the probiotic Lacticaseibacillus rhamnosus TOM 22.8 (DSM 33500) strain, orally administrated, to treat vaginal dysbiosis. Overall, 80 women, with signs and symptoms of vaginal dysbiosis, were enrolled and allocated to the treatment group (A, n=60), who took 1 capsule of the probiotic strain for 10 consecutive days, or the non-treatment group (B, n=20), who did not receive any treatment. Clinical (vaginal signs and symptoms; pH of the vaginal fluid; Amsel criteria; Nugent score; Lactobacillary grade) and microbiological examinations were performed at baseline (T0), 10 days (T1), and 30 (T2) days after the oral administration of the probiotic TOM 22.8 strain. The latter resulted in a restoration of the physiological pH, accompanied by remission or attenuation of clinical signs and symptoms as well as the improvement of the quality of life (QoL). Microbiological data revealed a significant reduction of potentially pathogenic bacteria. The administration of the L. rhamnosus TOM 22.8 probiotic strain could be proposed as an effective strategy for the treatment of vaginal dysbiosis.

Prevalence of Bacterial Vaginosis and Its Association With Preterm Birth in a Tertiary Care Hospital in Chennai: A Cross-Sectional Study.

Background The most common preventive cause of premature labour is ascending infections.This study was conducted to evaluate the association between bacterial vaginosis (BV) and preterm labour in antenatal women and determine the significance of using the Amsel criteria to screen for BV. Methods This was a hospital-based cross-sectional study conducted among 100 antenatal mothers in the second trimester attending the antenatal OPD at a tertiary care hospital in Chennai from October 2019 to September 2021 after obtaining clearance from the institutional ethics committee and written informed consent from the study participants. Data were entered in Excel (Microsoft Corporation, Redmond, WA) and analysed in SPSS (IBM Corp., Armonk, NY). Results According to the Amsel criteria, BV was detected in 21 women (21%). Neither maternal age nor parity had an effect on the study group. There was a statistically significant relationship (p < 0.05) between the mode of delivery, preterm labour, and the study group. Of the 21 positive BV cases, 95% were positive for clue cells and only 5% were positive for gram-negative bacteria. Consequently, BV was found to be associated with early labour. There is no association between BMI and BV (p > 0.005). Conclusion In the current study, BV was shown to be associated with preterm labour. Our study underscores the significance of the Amsel criteria as a valuable tool for screening BV in antenatal women.

Effectiveness and Costs of Molecular Screening and Treatment for Bacterial Vaginosis to Prevent Preterm Birth: The AuTop Randomized Clinical Trial

ABSTRACT One of the risk factors for preterm birth (PTB) is bacterial vaginosis (BV), a common, often asymptomatic, vaginal dysbiosis. The earlier BV is diagnosed based on gestational age, the higher the risk of PTB. The effectiveness of a screen-and-treat strategy for BV during pregnancy remains a source of debate. One meta-analyses, including 5 studies and 2346 patients, showed a benefit to screen and treat using clindamycin. Another, with 21 studies and 7847 patients, did not recommend BV screening but observed reductions in preterm delivery by 50% and miscarriages by 80%. In another systematic review, with 48 studies, there was varying accuracy across conventional screening tests for BV and suggested no or inconclusive efficacy in the treatment of asymptomatic BV in the general obstetric population and in those with a history of preterm delivery. Based on these studies, French and international organizations recommend against screening for BV with conventional diagnosis tools in low-risk populations. However, molecular diagnostic tools have been shown to be more accurate in identifying vaginal microbiota than conventional tools, such as clinical diagnosis based on Amsel or Nugent criteria. Molecular tools have been shown to provide an objective, reproducible, quantitative diagnosis of BV, identifying emergent pathogen species, such as Atopobium vaginae (now known as Fannyhessea vaginae). To date, no randomized studies have been conducted to assess the impact of molecular tools on a screen-and-treat intervention to BV. The aim of this study was to assess whether a screen-and-treat intervention using a molecular diagnostic tool is cost-effective in reducing the rate of PTB. The AuTop Trial was a prospective, open-label superiority trial conducted in 19 French maternity hospitals from March 9, 2015, to December 18, 2017. Included were adult women in early pregnancy (&lt;20 weeks of gestation), with no history of PTB or late abortion and no major risk factors for prematurity. Excluded were patients who had extrauterine pregnancy or nonprogressive pregnancy, or were treated with antibiotics a week before inclusion in the study. Women were randomly assigned 1:1 to undergo molecular screening and treatment (intervention group) or receive usual care (control group). The intervention group was asked to self-collect vaginal swabs and return them within 15 days of collection for each month until 28 weeks of gestation. If BV was detected, treatment with azithromycin (1 g repeated after 48 hours) or amoxicillin (2 g/d for 7 days) was provided within 48 hours. A molecular biology-based rapid diagnostic tool designed for point-of-care testing was developed using real-time polymerase chain reaction assays to quantify DNA levels of A. vaginae. The tool's specificity, sensitivity, positive predictive value, and negative predicative value of the tool were 99%, 95%, 95%, and 99%, respectively, compared with other diagnostic techniques. The control group received usual care with no systematic screening of BV. A total of 6671 women were randomly assigned 1:1 to the intervention group (n = 3333) or control group (n = 3338). At inclusion, a total of 3438 were nulliparous pregnancies, with 1671 in the intervention group and 1767 in the control group. In the intention-to-treat analysis, no reduction in the rate of PTB was observed between the intervention and control group (3.8% vs 4.6%, respectively; risk ratio, 0.83; 95% confidence interval [CI], 0.66–1.05; P = 0.12). The average cost of intervention per woman was €203.60 (US $218.00). No significant differences were observed in the total cost in the intervention group versus control group (€3344.30 [US $3580.50] vs €3272.90 [US $3504.10]). In addition, no evidence of superiority was observed for the intervention strategy compared with usual care. However, in the nulliparous subgroup, the number of PTBs was significantly lower in the intervention group (3.6%; 95% CI, 2.9–4.6) than the control group (5.9%, 95% CI, 4.8–7.2), and the cost was nonsignificant. In conclusion, the molecular diagnostic tool for screening and treating BV did not significantly reduce the risk of PTBs. Although no significant benefit was found in the overall population, the screen-and-treat strategy using a molecular tool was more effective than usual care in reducing PTBs among nulliparous pregnant women.

Evaluation of Various Diagnostic Strategies for Bacterial Vaginosis, Including a New Approach Based on MALDI-TOF Mass Spectrometry.

Bacterial vaginosis (BV) is a common dysbiosis of unclear etiology but with potential consequences representing a public health problem. The diagnostic strategies vary widely. The Amsel criteria and Nugent score have obvious limitations, while molecular biology techniques are expensive and not yet widespread. We set out to evaluate different diagnostic strategies from vaginal samples using (1) a combination of abnormal vaginal discharge and vaginal pH > 4.5; (2) the Amsel-like criteria (replacing the "whiff test" with "malodorous discharge"); (3) the Nugent score; (4) the molecular quantification of Fannyhessea vaginae and Gardnerella vaginalis (qPCR); (5) and MALDI-TOF mass spectrometry (we also refer to it as "VAGI-TOF"). Overall, 54/129 patients (42%) were diagnosed with BV using the combination of vaginal discharge and pH, 46/118 (39%) using the Amsel-like criteria, 31/130 (24%) using qPCR, 32/130 (25%) using "VAGI-TOF", and 23/84 (27%) using the Nugent score (not including the 26 (31%) with intermediate flora). Of the 84 women for whom the five diagnostic strategies were performed, the diagnosis of BV was considered for 38% using the combination of vaginal discharge and pH, 34.5% using the Amsel-like criteria, 27% using the Nugent score, 25% using qPCR, and 25% using "VAGI-TOF". When qPCR was considered as the reference, the sensitivity rate for BV was 76.2% for the combination of vaginal discharge and pH, 90.5% for the Amsel-like criteria, 95.2% for the Nugent score, and 90.5% for "VAGI-TOF", while the specificity rates were 74.6%, 84.1%, 95.3%, and 95.3%, respectively. When the Nugent score was considered as the reference, the sensitivity for BV was 69.6% for the combination of vaginal discharge and pH, 82.6% for the Amsel-like criteria, 87% for qPCR, and 78.7% for "VAGI-TOF", while the specificity rates were 80%, 94.3%, 100%, and 97.1%, respectively. Overall, the use of qPCR and "VAGI-TOF" provided a consistent diagnosis of BV, followed by the Nugent score. If qPCR seems tedious and for some costly, "VAGI-TOF" could be an inexpensive, practical, and less time-consuming alternative.

Effect of Cymbopogon olivieri-based herbal vaginal product on bacterial vaginosis.

Bacterial vaginosis is the most common vaginal infection in reproductive-age women. If it is not treated, the quality of life will be reduced. In this study, the herbal medicine product Cymbopogon olivieri was used for its treatment. This study was conducted with 90 women. The patients were randomly divided into two groups of 45: Cymbopogon olivieri and metronidazole. The treatment period was 7 days for each group. Improvement status was determined by eliminating at least three out of four of Amsel's criteria. A new variable with two order levels (negative and positive) was constructed. This new variable shows the status of the treatment process. Chi-square and Fisher's exact tests were used to examine the relationship between the new variable and treatment status. The results demonstrate that Cymbopogon olivieri and metronidazole significantly reduced the burning, itching, malodor, abnormal vaginal discharge, pH, clue cell, and positive whiff test (p<0.05). The findings also demonstrate that neither treatment was statistically different from the other for at least three of Amsel's criteria. This study shows that the effect of Cymbopogon olivieri on bacterial vaginosis is similar to that of metronidazole. Hence, Cymbopogon olivieri is a suitable option to treat bacterial vaginosis.

Molecular Testing for the Diagnosis of Bacterial Vaginosis.

Previously established diagnostic approaches for the diagnosis of bacterial vaginosis (BV), such as the Amsel criteria or the Nugent scoring system, do not always correspond to modern trends in understanding the etiology and pathogenesis of polymicrobial conditions. Inter-examiner variability and interpretation of data complicate the wet mount microscopy method. Gram staining of smears does not always provide reliable information regarding bacterial taxa, biofilms, or vaginal dysbiosis. Therefore, the introduction of molecular techniques into clinical practice is extremely relevant. Molecular approaches allow not only the diagnosis of BV but also provide an assessment of microbial composition, which is especially important in the differential diagnosis of vaginal infections. The current review represents an expert opinion on BV diagnosis and is based on extensive experience in the field of vaginal infection diagnosis and treatment.

Experience with clindamycin and lactic acid in the treatment of bacterial vaginosis

Background. Currently, the search for the most effective methods to treat bacterial vaginosis remains relevant because of the high recurrence rate and resistance of the associated bacteria to antimicrobial drugs, along with the potential side effects of antibiotic therapy. This study aimed to assess the effectiveness and tolerability of using clindamycin and lactic acid sequentially, in comparison to lactic acid monotherapy, for women with bacterial vaginosis.&#x0D; Materials and methods. An open, randomized, comparative clinical study was conducted with 20 women (aged 18–45 years) who had bacterial vaginosis diagnosed according to R. Amsel criteria. The patients were randomly allocated into two groups, each comprising 10 patients. Group 1 took lactic acid, whereas group 2 employed clindamycin and lactic acid. After 14 days, clinical and laboratory efficacy was assessed based on Amsel criteria.&#x0D; Results. Objective and subjective symptoms such as vaginal discharge of whitish-gray color with unpleasant odor were not observed in both groups 2 weeks after the end of treatment. Positive dynamics of vaginal pH was recorded in both groups; however, a more pronounced effect was observed in women who used clindamycin and lactic acid.&#x0D; Conclusions. Both sequential clindamycin and lactic acid monotherapy demonstrated high clinical efficacy and good tolerability. Posttreatment pH values did not differ significantly between the two groups; however, a greater pH deviation was observed in the clindamycin and lactic acid sequential group. Further evaluations of long-term results are necessary.

A Cross Sectional Study on Prevalence of Bacterial Vaginosis in Preterm and Term Labor

Background: The aim is to examine bacterial vaginosis (BV) in women with preterm and term labor, explore the link between bacterial vaginosis and preterm labor (PTL), and analyze complications for both mother and baby related to bacterial vaginosis. Design: Hospital based cross sectional study. Materials and Method: We had conducted an observational study at Basaveshwara Medical College and Hospital, involving 100 pregnant patients with preterm and term labor (50 patients in each group). Eligible patients attending the Obstetrics and Gynecology Outpatient Department (OBG OPD) and inpatient department will be included. Bacterial vaginosis will be determined using Amsel's criteria, which include evaluating discharge characteristics, vaginal pH, amine odor with KOH test, and presence of clue cells under microscopic examination. Additionally, vaginal swabs will undergo Gram staining. Results: The percentage of patients meeting Amsel's criteria for diagnosing bacterial vaginosis was significantly higher in the preterm labor group compared to the term labor group, with a statistically significant difference. According to Amsel's criteria, the prevalence of bacterial vaginosis was 30% in the preterm labor group and 2% in the term labor group. Conclusion: Bacterial vaginosis is a significant risk factor for preterm labor. Hence, conducting tests for bacterial vaginosis and promptly treating it can help reduce the risk of preterm labor.

Association of Chlamydia trachomatis burden with the vaginal microbiota, bacterial vaginosis, and metronidazole treatment.

Bacterial vaginosis (BV), a dysbiosis of the vaginal microbiota, is a common coinfection with Chlamydia trachomatis (Ct), and BV-associated bacteria (BVAB) and their products have been implicated in aiding Ct evade natural immunity. Here, we determined if a non-optimal vaginal microbiota was associated with a higher genital Ct burden and if metronidazole, a standard treatment for BV, would reduce Ct burden or aid in natural clearance of Ct infection. Cervicovaginal samples were collected from women at enrollment and, if testing positive for Ct infection, at a follow-up visit approximately one week later. Cervical Ct burden was assessed by inclusion forming units (IFU) and Ct genome copy number (GCN), and 16S rRNA gene sequencing was used to determine the composition of the vaginal microbiota. We observed a six-log spectrum of IFU and an eight-log spectrum of GCN in our study participants at their enrollment visit, but BV, as indicated by Amsel's criteria, Nugent scoring, or VALENCIA community state typing, did not predict infectious and total Ct burden, although IFU : GCN increased with Amsel and Nugent scores and in BV-like community state types. Ct burden was, however, associated with the abundance of bacterial species in the vaginal microbiota, negatively with Lactobacillus crispatus and positively with Prevotella bivia. Women diagnosed with BV were treated with metronidazole, and Ct burden was significantly reduced in those who resolved BV with treatment. A subset of women naturally cleared Ct infection in the interim, typified by low Ct burden at enrollment and resolution of BV. Abundance of many BVAB decreased, and Lactobacillus increased, in response to metronidazole treatment, but no changes in abundances of specific vaginal bacteria were unique to women who spontaneously cleared Ct infection.

A COMPARATIVE OBSERVATIONAL STUDY ON EFFECTIVENESS OF PROBIOTICS AND ANTIBIOTICS IN BACTERIAL VAGINOSIS

Introduction: Bacterial vaginosis is a common vaginal dysbiosis in women of reproductive age. Bacterial vaginosis is a dysbiosis characterized by a reduction of Lactobacillus species, such as L. crispatus, L. gasseri, and L. Jensenii. Anti-microbial resistance of BV pathogens and low long-term cure rates have been increasing in the few years. Aim: Probiotics are proposed as an alternative treatment for BV applying live micro-organisms with the capacity to confer health benefits to the patient. Methods: Patients with white discharge per vagina with or without foul smell, and itching visiting Obstetrics and Gynecology OPD are subjected to Amsel criteria. Those test positive for 3 out of 4 are diagnosed to have bacterial vaginosis and were enrolled in the study. Result: Highest prevalence of bacterial vaginosis was at the age group of 26-30 years (28%), with the lowest prevalence (16%) above 40 years of age. Among group A (probiotics), 68% and 32% of women were in not working and working groups, respectively, when compared with group B (antibiotics), 64% and 36% of women were in not working and working groups. Nulligravida (28% and 32%), Singleton Pregnancy (32% and 16%) in Group A and Group B. We observed that patients treated with both antibiotics (50%) and probiotics (50%) had similar recurrence rates of BV. Conclusion: Hence it would be prudent to prefer probiotics in patients with BV, as they colonize other normal commensals and have similar efficacy as that of antibiotics. The other beneficial factors of probiotics include acceptability to patients and nil side effect profile.

Vaginal Microbiota Molecular Profiling in Women with Bacterial Vaginosis: A Novel Diagnostic Tool.

Bacterial vaginosis (BV) is a most common microbiological syndrome. Multiplex next-generation sequencing (NGS) or molecular tests allow a complete and accurate vaginal microbiota profiling in order to determine the primary causative agent. Due to the high costs and limited availability of NGS, the multiplex real-time PCR draws more attention. The present study aimed to evaluate the microbial composition and dominant lactobacilli species in non-pregnant women with bacterial vaginosis using a multiplex RT-PCR test and determine its diagnostic significance. In total, 331 women complaining of vaginal discharge were included. BV was confirmed upon clinical examination and Nugent criteria. A real-time PCR test was carried out with a new Femoflor test, which identifies opportunistic bacteria, STD pathogens, and some viruses. According to the results, the rate of lactobacilli is significantly reduced in BV-affected patients when compared to healthy women. Moreover, the rate of L. crispatus significantly decreases, while the rate of L. iners remains high. Among obligate anaerobic bacteria, Gardnerella vaginalis was the most prevalent in women with BV. The Femoflor test demonstrated high sensitivity and specificity for diagnosing BV. Moreover, the test allows the identification of infection in women with intermediate vaginal microbiota, as well as STD pathogens, and viruses. Thus, the application of real-time PCR tests can be effectively used in vaginal microbiota evaluation in women with BV, intermediate vaginal microbiota, and healthy women. In addition, this test may be used as an alternative to the Amsel criteria and Nugent scoring method in diagnosing BV.

Comparison of the Frequency of Vaginal Infections in Women with Premature Delivery and Women with Term Delivery in Ali Ibn Abitaleb Hospital of Zahedan in 2018

Introduction: Premature birth is one of the most common causes of infant mortality worldwide. In many countries, preterm birth rates increased between 1990 and 2010. Vaginal infections are important causes of preterm labor (PTL). Therefore, this study aimed to determine the role of vaginal infections in causing preterm labor. Method: This study was a case-control study. The target population was pregnant women referring to Ali Ibn Abitaleb Hospital in Zahedan, Iran, in 2018 who were aged 20 to 38 years and were diagnosed with PTL. The control group included an equal number of women with the same age range but term labor. To investigate candida, trichomonas, bacterial vaginosis, and group B streptococcali, swab samples were taken from the vagina and rectum. Different laboratory methods were performed to isolate the above-mentioned microorganisms, including microscopy of wet mount smear, Gram stain, culture on Sabouraud agar, and 5% sheep blood agar. Moreover, four Amsel criteria were used to diagnose bacterial vaginosis. At last, the collected data were analyzed by SPSS-19 software with a p-value of 0.05. Results: A total of 300 patients were included in the study, and the mean age was not statistically significantly different between the two groups of PTL and term labor. No statistically significant difference was observed in the frequency of vaginal candidiasis (P=0.081), bacterial vaginosis (P=0.906), and trichomonas infection (P=0.904) between the two groups. Conclusion: It seems that the genital infections examined in this study do not play a role in increasing the prevalence of premature birth.

Performance and Safety of a New Medical Device (Polybactum) for Reducing the Recurrence Rate of Bacterial Vaginosis: Protocol for a Multicenter, Open-Label, Noncontrolled International Clinical Trial (POLARIS Study).

The medical literature has reported that recurrent bacterial vaginosis (RBV) has a relapse rate of 35% within 3 months and 60% within 12 months after antibiotic administration. Products that are able to provide a barrier effect against the biofilm produced by Gardnerella vaginalis could play a role in improving the results of bacterial vaginosis (BV) treatment. This study aims to assess the performance and safety of a medical device (Polybactum) containing polycarbophil, lauryl glucoside, and glycerides (PLGG) for reducing the rate of recurrence of BV. The study includes women who are aged above 18 years, are willing to provide signed informed consent, have a diagnosis of BV according to the Amsel criteria, and have been affected by at least 2 episodes of RBV in the last 12 months. The trial includes 2 phases. In the first phase (according to an open-label noncontrolled design), the treatment involving PLGG is administered for 3 cycles and is followed by a 1-month period of follow-up without treatment. In the second phase, a 9-month follow-up period is envisaged. Thus, for each patient, a 10-month follow-up period without treatment is planned. The study involves 5 centers (2 in Italy and 3 in Romania). We calculated a sample size of 44 pairs to achieve a power of 80% and a 1-sided significance of 5% for detecting a difference of 0.25 between marginal proportions, in comparison with the mean recurrence rate of BV reported in the medical literature. We estimated a potential dropout rate of 20%, and thus, we decided to enroll 55 patients (1-group chi-square test). The study received ethics approval in 2016 in Romania and 1 year later in Italy. Recruitment started in September 2016. An interim analysis was performed in 2019, and full study analysis results are expected in July 2023. The tested medical device involving PLGG could modify the mechanisms involved in the pathogenesis of BV and could improve microbiological parameters owing to the acidifying effect on vaginal pH. We believe that the findings of our study could be useful for other investigators who want to test different products against RBV using a standardized protocol and standardized procedures. ClinicalTrials.gov NCT02863536; https://clinicaltrials.gov/ct2/show/NCT02863536. RR1-10.2196/42787.

Sociodemographic and Behavioral Predictors of Recurrent Bacterial Vaginosis Among Sexual Health Clinic Patients in New York City From 2014 to 2018.

Bacterial vaginosis (BV) is associated with adverse reproductive outcomes, and recurrence is common. We examined factors associated with BV recurrence using electronic medical record data for patients attending New York City Department of Health and Mental Hygiene sexual health clinics from 2014 to 2018. Clinician-diagnosed BV was defined using a clinical BV diagnosis code based on Amsel criteria. Recurrent BV was defined as any BV diagnosis occurring more than 30 days after the previous diagnosis. Adjusted hazard ratios (AHRs) for the relationship between potential risk factors and recurrent BV were estimated using conditional gap-time models. The data set contained 14,858 patients with at least one BV diagnosis. Of these, 46.3% (n = 6882) had at least 1 follow-up visit to a sexual health clinic between January 2014 and December 2018. Of those with a follow-up visit, 53.9% (n = 3707) had ≥1 recurrent BV episode, with 33.7% (n = 2317) experiencing recurrence within 3 months. In the multivariable model, using a hormonal intrauterine device (IUD; AHR, 1.31; 95% confidence interval [CI], 1.14-1.49) or copper IUD (AHR, 1.17; 95% CI, 1.01-1.37), having a history of trichomonas (AHR, 1.23; 95% CI, 1.12-1.36), and being non-Hispanic Black (AHR, 1.11; 95% CI, 1.04-1.18) were associated with a higher risk of BV recurrence, whereas using non-IUD hormonal contraception was associated with reduced risk (AHR, 0.88; 95% CI, 0.80-0.98). Risk of BV recurrence was increased among patients using an IUD, whereas it was reduced in patients using non-IUD hormonal contraception.