Treatment Of Bacterial Vaginosis Research Articles

Formulation and characterization of pressure-assisted microsyringe 3D-printed scaffolds for controlled intravaginal antibiotic release

Bacterial vaginosis (BV) is a highly recurrent vaginal condition linked with many health complications. Topical antibiotic treatments for BV are challenged with drug solubility in vaginal fluid, lack of convenience and user adherence to daily treatment protocols, among other factors. 3D-printed scaffolds can provide sustained antibiotic delivery to the female reproductive tract (FRT). Silicone vehicles have been shown to provide structural stability, flexibility, and biocompatibility, with favorable drug release kinetics. This study formulates and characterizes novel metronidazole-containing 3D-printed silicone scaffolds for eventual application to the FRT. Scaffolds were evaluated for degradation, swelling, compression, and metronidazole release in simulated vaginal fluid (SVF). Scaffolds retained high structural integrity and sustained release. Minimal mass loss (<6%) and swelling (<2%) were observed after 14 days in SVF, relative to initial post-cure measurements. Scaffolds cured for 24 hr (50 °C) demonstrated elastic behavior under 20% compression and 4.0 N load. Scaffolds cured for 4 hr (50 °C), followed by 72 hr (4 °C), demonstrated the highest, sustained, metronidazole release (4.0 and 27.0 µg/mg) after 24 hr and 14 days, respectively. Based upon daily release profiles, it was observed that the 24 hr timepoint had the greatest metronidazole release of 4.08 μg/mg for scaffolds cured at 4 hr at 50 °C followed by 72 hr at 4 °C. For all curing conditions, release of metronidazole after 1 and 7 days showed > 4.0-log reduction in Gardnerella concentration. Negligible cytotoxicity was observed in treated keratinocytes comparable to untreated cells, This study shows that pressure-assisted microsyringe 3D-printed silicone scaffolds may provide a versatile vehicle for sustained metronidazole delivery to the FRT.

Development of Thermoresponsive Hydrogels with Mucoadhesion Properties Loaded with Metronidazole Gel-Flakes for Improved Bacterial Vaginosis Treatment.

Bacterial vaginosis is an infectious disease that has significantly affected women's health. Metronidazole has been widely used as a drug for treating bacterial vaginosis. Nevertheless, the currently available therapies have been found to be inefficient and inconvenient. Here, we developed the combination approach of gel flake and thermoresponsive hydrogel systems. The gel flakes were prepared using gellan gum and chitosan, showing that the incorporation of metronidazole was able to provide a sustained release pattern for 24 h with an entrapment efficiency of >90%. Moreover, the gel flakes were incorporated into Pluronics-based thermoresponsive hydrogel using the combination of Pluronic F127 and F68. The hydrogels were found to exhibit the desired thermoresponsive properties, showing sol-gel transition at vaginal temperature. Following the addition of sodium alginate as a mucoadhesive agent, the hydrogel was retained in the vaginal tissue for more than 8 h, with more than 5 mg of metronidazole retained in the ex vivo evaluation. Finally, using the bacterial vaginosis infection model in rats, this approach could decrease the viability of Escherichia coli and Staphylococcus aureus with reduction percentages of more than 95% after 3 days of treatment, with the healing ability similar to normal vaginal tissue. In conclusion, this study offers an effective approach for the treatment of bacterial vaginosis.

КОМПЛЕКСНЫЙ ПОДХОД К ЛЕЧЕНИЮ БАКТЕРИАЛЬНОГО ВАГИНОЗА У ПАЦИЕНТОК С СИНДРОМОМ ПОЛИКИСТОЗНЫХ ЯИЧНИКОВ

A two-stage complex method of therapy of bacterial vaginosis (BV) in 29 patients with polycystic ovary syndrome (PCOS) is proposed, consisting in the use of standard metronidazole therapy (vaginal suppositories of 500 mg 2 times a day for 7 days) at the first stage and therapy with Acylact DUO at the second stage (1 candle in the vagina per night of 10 days), effective in relieving clinical manifestations and preventing recurrence of vaginal dysbiosis. Intravaginal administration of metronidazole to patients with polycystic ovary syndrome (PCOS) and bacterial vaginosis (BV) significantly reduced the concentration of anaerobic microorganisms. The appointment with Acylact DUO stimulated the growth of its own lactobacilli and helped to reduce the number of relapses of the disease by increasing the protective properties in the vagina. Normalization of the vaginal microflora was noted in all patients included in the study. After three months, normal vaginal biocenosis was detected in 26 patients (89.6% of women) according to a control smear study to detect key cells as markers of bacterial vaginosis. Clinical manifestations of bacterial vaginosis (itching, burning, pathological discharge) were not detected in any patient. Thus, the conducted study showed high efficiency of complex two-stage treatment of bacterial vaginosis, consisting in the use of vaginal candles containing metronidazole at the first stage, followed by the drug Acylact DUO in patients with polycystic ovary syndrome, provided timely correction of hormonal and metabolic disorders in them.

Acceptability of Single-dose Clindamycin Gel for Bacterial Vaginosis: A Randomized Controlled Trial

The goal of this study was to assess the acceptability of a single-dose bioadhesive 2% clindamycin vaginal gel for bacterial vaginosis (BV). This double-blind, placebo-controlled, randomized study compared a new clindamycin gel with placebo gel (2:1 ratio). The primary objective was efficacy; secondary objectives were safety and acceptability. Subjects were evaluated at screening, days 7 to 14 (Day 7-14), and days 21 to 30 (test-of-cure [TOC]). An acceptability questionnaire with 9 questions was administered at the Day 7-14 visit, and a subset of questions (#7-#9) was asked again at the TOC visit. At Visit 1, subjects were provided with a daily electronic diary (e-Diary) to collect information regarding study drug administration, vaginal discharge, odor, itching, and any other treatments used. Study site staff reviewed e-Diaries at the Day 7-14 and TOC visits. A total of 307 women with BV were randomized to treatment (204 to the clindamycin gel group and 103 to the placebo gel group). Most (88.3%) reported at least one previously diagnosed BV episode, and more than one half (55.4%) had experience with other vaginal treatments for BV. At the TOC visit, almost all (91.1%) of the clindamycin gel subjects described their overall experience with the study drug as "satisfied" or "very satisfied," 95.8% indicated that they would be "likely" or "very likely" to use the product again if it became available after the study and they had BV again, and 93.7% would be "likely" or "very likely" to recommend their treatment to a friend who had BV. Almost all (90.2%) clindamycin-treated subjects responded that application was "clean" or "fairly clean," as opposed to "neither clean nor messy," "fairly messy," or "messy." Although 55.4% experienced leakage in the days after application, only 26.9% of those indicated that it was bothersome. Subjects receiving clindamycin gel also reported improvement in both odor and discharge, commencing shortly after dosing and continuing through the assessment period, regardless of whether they met the critical cure criteria. A single dose of a new bioadhesive 2% clindamycin vaginal gel showed rapid resolution of symptoms and was highly acceptable as a treatment for bacterial vaginosis. gov identifier: NCT04370548.

Lactobacillus crispatus-loaded electrospun fibers yield viable and metabolically active bacteria that kill Gardnerella in vitro

Bacterial vaginosis (BV) is a common condition that affects one-third of women worldwide. BV is characterized by low levels of healthy lactobacilli and an overgrowth of common anaerobes such as Gardnerella. Antibiotics for BV are administered orally or vaginally; however, approximately half of those treated will experience recurrence within 6 months. Lactobacillus crispatus present at high levels has been associated with positive health outcomes. To address the high recurrence rates following BV treatment, beneficial bacteria have been considered as an alternative or adjunct modality. This study aimed to establish proof-of-concept for a new long-acting delivery vehicle for L. crispatus. Here, it is shown that polyethylene oxide (PEO) fibers loaded with L. crispatus can be electrospun with poly(lactic-co-glycolic acid) (PLGA) fibers (ratio 1:1), and that this construct later releases L. crispatus as metabolically viable bacteria capable of lactic acid production and anti-Gardnerella activity. Probiotic-containing fibers were serially cultured in MRS (deMan, Rogosa, Sharpe) broth with daily media replacement and found to yield viable L. crispatus for at least 7 days. Lactic acid levels and corresponding pH values generally corresponded with levels of L. crispatus cultured from the fibers and strongly support the conclusion that fibers yield viable L. crispatus that is metabolically active. Cultures of L. crispatus-loaded fibers limited the growth of Gardnerella in a dilution-dependent manner during in vitro assays in the presence of cultured vaginal epithelial cells, demonstrating bactericidal potential. Exposure of VK2/E6E7 cells to L. crispatus-loaded fibers resulted in minimal loss of viability relative to untreated cells. Altogether, these data provide proof-of-concept for electrospun fibers as a candidate delivery vehicle for application of vaginal probiotics in a long-acting form.

Prevalence, Associated Factors, and Appropriateness of Empirical Treatment of Trichomoniasis, Bacterial Vaginosis, and Vulvovaginal Candidiasis among Women with Vaginitis.

Trichomoniasis (TV), bacterial vaginosis (BV), and vulvovaginal candidiasis (VVC) are the most common causes of vaginitis. This study investigated the prevalence of these diagnoses, their associated factors, and the appropriateness of the empirical treatment. From March 25, 2019, to June 17, 2022, 429 women with symptoms or signs of vaginitis were enrolled in a hospital in northern Taiwan with 438 episodes of vaginitis. Vaginal swabs were collected for Gram's staining, in vitro cultures for Trichomonas vaginalis, bacteria, and yeasts, and multiplex PCR assay for TV, BV, and VVC. Their empirical treatments were recorded. Factors associated with different etiologies of vaginitis were sought in multivariable logistic regression models. The prevalence of TV, BV, and VVC were 2.1%, 22.8%, and 21.7%, respectively, while coinfections of BV and VVC, TV and BV, TV and VVC, and triple infection occurred in 5.0%, 0.2%, 0.2%, and 0.7%, respectively. Multivariable analyses revealed that having multiple sexual partners was associated with TV and BV (adjusted odds ratio [aOR] 9.756 and 3.246, respectively), while menopausal women were less likely to have VVC (aOR 0.184). Moreover, dysuria was associated with TV (aOR 4.981), vaginal itch and pelvic pain with VVC (aOR 3.223 and 0.425, respectively), and discharge pH > 4.5 with BV (aOR 1.767). Other clinical symptoms and pelvic examination features had limited value for differential diagnosis. Among the 78 empirical antifungal and metronidazole prescriptions, 55.2% were ineffective or unnecessary. Our study highlights the importance to integrate appropriate diagnostic tools into the clinical care of women with vaginitis. IMPORTANCE Vaginal complaints are widespread among women and are associated with emotional, physical, and economic burdens with challenges in their diagnosis and management. In this survey, we identified that 40% of vaginitis in Taiwan was caused by either trichomoniasis, bacterial vaginosis, vulvovaginal candidiasis, or a combination of these infections. Our data suggested that typical physical findings appeared infrequently among women with these infections and their empirical treatments were frequently inappropriate. Our findings highlighted the importance of integrating proper diagnostic tools into clinical practice to improve the diagnosis and management of vaginitis, as recommended by national and international guidelines.

Fighting polymicrobial biofilms in bacterial vaginosis.

Bacterial vaginosis (BV) is the most common cause of vaginal discharge and is often associated with other health consequences mainly in pregnant women. BV is described by an imbalance in the vaginal microbiota where strictly and facultative anaerobic bacteria outgrow the lactic acid- and hydrogen peroxide-producing Lactobacillus species. The species involved in BV are capable to grow and form a polymicrobial biofilm in the vaginal epithelium. The treatment of BV is usually performed using broad-spectrum antibiotics, including metronidazole and clindamycin. However, these conventional treatments are associated with high recurrence rates. The BV polymicrobial biofilm may have an important role on the treatment outcome and is accounted as one of the factors for treatment failure. Other possible reasons for treatment failure include the presence of species resistant to antibiotics or the chance of reinfection after treatment. Therefore, novel strategies to increase the rates of treatment have been studied namely the use of probiotics and prebiotics, acidifying agents, antiseptics, plant-based products, vaginal microbiota transplantation, and phage endolysins. Although some of them are still in an initial phase of development with very preliminary results, they show great perspectives for application. In this review, we aimed to study the role of the polymicrobial nature of BV in treatment failure and explore a few alternatives for treatment.

Возможность применения крема дозированного Ацилакт Дуо при бактериальном вагинозе

Bacterial vaginosis is a clinical condition in which the normal vaginal microflora, predominantly lactobacilli, is replaced by other microorganisms, mainly anaerobes. The goal of treating bacterial vaginosis is to restore the normal microflora of the vagina, to delay the growth of microorganisms that are not characteristic of this vaginal microcenosis. The purpose of the study was to evaluate the effectiveness of various methods of combined two-stage treatment of bacterial vaginosis in women of reproductive age. Material and methods. The study included 50 patients aged 18 to 45 years (mean age 29.6 ± 4.5 years) with bacterial vaginosis. The first group consisted of 25 patients who received Clindamycin 2% cream for 7 days, dose vaginally at night. For the second stage of therapy in this 1 group, acidophilus bacteria + vitamin-mineral-protein-peptide complex Superlimfly (Acylact Duo) were used, suppository time per day at night intravaginally for 10 days. The second group consisted of 25 patients who received Clindacimin cream for 7 days, dose vaginally at night. For the second stage of therapy, a preparation containing a lyophilized culture of lactobacilli L. casei rhamnosus Doderleini was used, at least 1 × 108 CFU, capsule in the vagina at night for 14 days. Results. The effectiveness of BV therapy was 49% (n = 46). The duration of remission was 24.1 ± 2.1 days (n = 24) in the group of women receiving adjuvant therapy with Acilact Duo dosed cream, and 19.9 ± 2 3. days (n = 22) in the comparison group. In all patients, the average vaginal pH before therapy was 5.5 ± 0.4. In group1 participants, after therapy, the pH was 4.54 ± 0.143 , in group 2 patients, the average vaginal pH was 4.976 ± 0.241. Among the patients of both groups, vaginal dysbiosis of varying severity was detected before treatment (normocenosis was not detected). After therapy, in patients of group, normocenosis of the vagina was achieved in 88% (22/25), in participants of group 2, normocenosis was noted in 72% (18/25). At visit (in 45 days) in women of the group 1 84% (21/25), in the participants of the group 2 – normocenosis was noted in 64% (16/25). Conclusions. Acidophilic bacteria + vitamin-mineral-protein-peptide complex Superlymfly (in which dosed Acylact Duo) quickly restores the optimal acidity of the vagina (pH value) and promotes the growth of the number of beneficial lactobacilli, as a result of which it creates an optimal and natural microflora that prevents the appearance of dysbiosis in patients of reproductive age

Vaginal Sheets with Thymbra capitata Essential Oil for the Treatment of Bacterial Vaginosis: Design, Characterization and In Vitro Evaluation of Efficacy and Safety.

We aimed to incorporate Thymbra capitata essential oil (TCEO), a potent antimicrobial natural product against bacterial vaginosis (BV)-related bacteria, in a suitable drug delivery system. We used vaginal sheets as dosage form to promote immediate relief of the typical abundant vaginal discharge with unpleasant odour. Excipients were selected to promote the healthy vaginal environment reestablishment and bioadhesion of formulations, while the TCEO acts directly on BV pathogens. We characterized vaginal sheets with TCEO in regard to technological characterization, predictable in vivo performance, in vitro efficacy and safety. Vaginal sheet D.O (acid lactic buffer, gelatine, glycerine, chitosan coated with TCEO 1% w/w) presented a higher buffer capacity and ability to absorb vaginal fluid simulant (VFS) among all vaginal sheets with EO, showing one of the most promising bioadhesive profiles, an excellent flexibility and structure that allow it to be easily rolled for application. Vaginal sheet D.O with 0.32 µL/mL TCEO was able to significantly reduce the bacterial load of all in vitro tested Gardnerella species. Although vaginal sheet D.O presented toxicity at some concentrations, this product was developed for a short time period of treatment, so this toxicity can probably be limited or even reversed when the treatment ends.

The problem of recurrent bacterial vaginosis: modern strategies

Objective: to evaluate the clinical tolerability, effectiveness and stability of the therapeutic result when using different regimens for the treatment of recurrent bacterial vaginosis (BV) in women of reproductive age.Materials and methods. 105 women of reproductive age with diagnosed recurrent symptomatic BV participated in the study. The participants were randomized into three comparable groups of 35 women each. A ten-day primary decontamination of the vaginal tract was carried out in all groups: intravaginal administration of the drug Tergynan for group 1 and Femiril suppositories in groups 2 and 3. After the initial treatment patients of group 3 received the vaginal probiotic suppositories Alactel Femi for 15 days, after that they used it twice a week No. 10.The effectiveness of BV therapy was evaluated immediately after the antibacterial course and after a 6-month follow-up period based on the results of clinical examination and determination of vaginal pH.Results. Subjective and objective signs of bacterial infection were not detected in all participants after the course of vaginal decontamination. The pH of vaginal secretion was within the normal range and did not differ statistically between the groups. After 6 month, according to the results of a gynecological examination and pH test, one recurrence of BV was confirmed in group 1 and 2. The patients of group 3 had no complaints about manifestations of reinfection, which, in combination with the data of pH-metry, allowed confirming the absence of BV recurrences in them. Additional use of a probiotic in a complex with lactic acid in group 3 was associated with a stable normalization of the acid-alkaline balance of the vaginal secretion: 4.43 ± 0.12 and 4.39 ± 0.14 in groups 1 and 2, respectively, against 4.02 ± 0 ,12 in the 3rd group (p &lt; 0.05).Conclusions. Obtained results indicate a more stable anti-relapse effectiveness and safety of the local use of Femiril, followed by the restoration of the physiological parameters of the vaginal biotope with a complex of probiotics and lactic acid in the Alactel femi. The effectiveness of this approach consists in combining the antibacterial effect of phytoextracts with the successive restoration of vaginal immunity and metabolism through persistent colonization of the mucous membrane with living lactobacilli of eubiotic origin.

Efficacy and safety of Fufang Furong Effervescent Suppository for the treatment of mixed vaginitis: a randomized, multicenter, and non-inferiority study

ObjectiveThe aim of this study was to compare the clinical efficacy and safety of Fufang Furong Effervescent Suppository and clindamycin phosphate cream for the treatment of bacterial vaginosis (BV) combined with aerobic vaginitis (AV). MethodsThis was a randomized, multicentre, active-controlled, non-inferiority clinical trial, with two parallel groups. Women diagnosed with BV + AV were randomly assigned to one of two groups and received 12-days of vaginal administration of either Fufang Furong Effervescent Suppository or clindamycin phosphate cream. The follow-up occurred during the 3–5 days (15–17 days) and 28 ± 3 days (40 ± 3 days) after drug administration, with the main assessments including the cure rate, BV, AV effective rate, recurrence rate, Lactobacillary grade (LBG) changes and adverse effects. The non-inferiority threshold of the non-inferiority test was set at 12%. ResultsFrom among the 600 eligible participants, 559 were randomly allocated to either the Furong group (n = 285) or the Clindamycin group (n = 274). The cure rate, BV, AV effective rate and the LBG changes of Furong group were not inferior to Clindamycin group in 15–17 days. The recurrence rate of BV + AV was also non-inferior to Clindamycin group at 40±3 days. During the follow-up period, no significant difference in the incidence of side effects were found between the two groups. ConclusionThe treatment of BV + AV using Fufang Furong Effervescent Suppository was not inferior to that of clindamycin phosphate cream in terms of cure rate, LBG changes, recurrence rate and adverse effects.

Efficacy of Probiotics in the Treatment of Adult Female Bacterial Vaginosis: A Meta-Analysis

Background: The purpose of this meta-analysis was to assess the value of probiotics in the treatment of adult female bacterial vaginosis (BV). Methods: We looked for published randomized controlled trials in PubMed, Embase and The Cochrane Library from the inception dates of the database to January 3rd, 2022. We conducted the search focusing on the treatment of adult female BV with probiotics. Two independent researchers screened the literature, evaluated the trial quality and extracted the data according to the inclusion and exclusion criteria. The primary outcome was the ratio of patients with BV with recurrence according to Nugent score 7–10 for recurrence after treatment. After heterogeneity was assessed using Review Manager 5.4 software, meta-analysis and bias assessment were performed using Stata 17.0 software. Results: A total of 5 articles representing 425 patients were included in this meta-analysis. Compared with antibiotics alone or antibiotics combined with a placebo, probiotics or probiotics combined with antibiotics significantly reduced the rate of recurrence at around the 30th day (risk ratio (RR) 0.11; 95 % confidence interval (CI) 0.03–0.33). However, in the analysis of heterogeneity, we found that after 30 days, the therapeutic effect of probiotics decreased with the extension of follow-up time (RR 0.50; 95% CI 0.24–1.03), (RR 1.24; 95% CI 0.88–1.76). Conclusions: The short-term efficacy of probiotics in the treatment of BV in adult female patients may be satisfactory, but the long-term efficacy of probiotic therapy may be suboptimal and still requires validation by further clinical trials.

Maternal and fetal outcomes of pregnant women with bacterial vaginosis.

Bacterial vaginosis (BV) is a common infection in women of reproductive age group because of vaginal dysbiosis. The impact of BV during pregnancy is still not well defined. The objective of this study is to assess the maternal-fetal outcome in women with BV. A prospective cohort study over one-year duration was conducted from December, 2014 until December, 2015, involving 237 women who presented with abnormal vaginal discharge, preterm labour or preterm prelabour rupture of membrane between 22- and 34-weeks period of gestation. Vaginal swabs were sent for culture and sensitivity, BV® Blue testing and PCR for Gardnerella vaginalis (GV). BV was diagnosed in 24/237 (10.1%) cases. The median gestational age was 31.6 weeks. GV was isolated from 16 out of 24 (66.7%) in the BV positive group. There was a significantly higher preterm birth rate, below 34 weeks (22.7% vs. 6.2%, p = 0.019) in women with BV. There was no statistically significant difference in maternal outcome such as clinical chorioamnionitis or endometritis. However, placental pathology revealed more than half (55.6%) of women with BV had histologic chorioamnionitis. Neonatal morbidity was significantly higher with exposure to BV, with a lower median birth weight, higher rate of neonatal intensive care unit admission (41.7% vs. 19.0%, p = 0.010), increased intubation for respiratory support (29.2% vs. 7.6%, p = 0.004) and respiratory distress syndrome (33.3% vs. 9.0%, p = 0.002). More research is needed to formulate guidelines for prevention, early detection and treatment of BV during pregnancy to reduce intrauterine inflammation and the associated adverse fetal outcomes.

The use of a lactic acid gel in the treatment and prevention of bacterial vaginosis and urinary tract infections as a challenge to antibacterial therapy. A literature review

Bacterial vaginosis and urinary tract infections are common conditions that lead to a decrease in the quality of life and significant economic costs. The review provides up-to-date information on the role of lactic acid in the microbiota of the vagina and urinary tract, as well as on the use of a lactic acid gel in these conditions. Bacterial vaginosis is associated with an increased risk of urinary tract infections. Antibacterial therapy demonstrates statistically significant results in treating exacerbation, but not preventing further relapses, which is due to the possible high ability of bacteria to form biofilms. Lactic acid, unlike hydrogen peroxide, is involved in maintaining the vaginal microbiota and enhancing its protective function against sexually transmitted infections, and indirectly affects the urinary microbiota. This may allow the use of lactic acid for the treatment and prevention of relapses in both bacterial vaginosis and urinary tract infections.

Microbiota disorders in bacterial vaginosis and the possibility of personalized therapy of the disease with the use of probiotics (review)

The review presents data on the etiology and treatment of bacterial vaginosis. Bacterial vaginosis is caused by the replacement of a protective microbiota in a lower part of a female reproductive tract with the pathogenic one. This disease is widespread in a world, in some cases it is asymptomatic, but is accompanied by complications, which include chorioamnionitis, inflammatory diseases of the pelvic organs, cervicitis, premature birth. In some cases, the disease is characterized by a recurrent course that requires a personalized treatment.

Antibiotic treatment of bacterial vaginosis to prevent preterm delivery: Systematic review and individual participant data meta-analysis.

Bacterial vaginosis (BV) increases preterm delivery (PTD) risk, but treatment trials showed mixed results in preventing PTD. Determine, using individual participant data (IPD), whether BV treatment during pregnancy reduced PTD or prolonged time-to-delivery. Cochrane Systematic Review (2013), MEDLINE, EMBASE, journal searches, and searches (January 2013-September 2022) ("bacterial vaginosis AND pregnancy") of (i) clinicaltrials.gov; (ii) Cochrane Central Register of Controlled Trials; (iii) World Health Organization International Clinical Trials Registry Platform Portal; and (iv) Web of Science ("bacterial vaginosis"). Studies randomising asymptomatic pregnant individuals with BV to antibiotics or control, measuring delivery gestation. Extraction was from original data files. Bias risk was assessed using the Cochrane tool. Analysis used "one-step" logistic and Cox random effect models, adjusting gestation at randomisation and PTD history; heterogeneity by I2 . Subgroup analysis tested interactions with treatment. In sensitivity analyses, studies not providing IPD were incorporated by "multiple random-donor hot-deck" imputation, using IPD studies as donors. There were 121 references (96 studies) with 23 eligible trials (11,979 participants); 13 studies (6915 participants) provided IPD; 12 (6115) were incorporated. Results from 9 (4887 participants) not providing IPD were imputed. Odds ratios for PTD for metronidazole and clindamycin versus placebo were 1.00 (95% CI 0.84, 1.17), I2 = 62%, and 0.59 (95% CI 0.42, 0.82), I2 = 0 before; and 0.95 (95% CI 0.81, 1.11), I2 = 59%, and 0.90 (95% CI: 0.72, 1.12), I2 = 0, after imputation. Time-to-delivery did not differ from null with either treatment. Including imputed IPD, there was no evidence that either drug was more effective when administered earlier, or among those with a PTD history. Clindamycin, but not metronidazole, was beneficial in studies providing IPD, but after imputing data from missing IPD studies, treatment of BV during pregnancy did not reduce PTD, nor prolong pregnancy, in any subgroup or when started earlier in gestation.

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 are promising adjuvant treatments to prevent recurrent bacterial vaginosis (BV) but may depend on the success of initial antibiotic treatment.

Treatment Success Following Standard Antibiotic Treatment for Bacterial Vaginosis Is Not Associated With Pretreatment Genital Immune or Microbial Parameters.

Bacterial vaginosis (BV) is a proinflammatory genital condition associated with adverse reproductive health outcomes, including increased HIV incidence. However, BV recurrence rates are high after standard antibiotic treatment. While the composition of the vaginal microbiota before BV treatment may be linked to BV recurrence, it is unclear whether the preceding genital immune milieu is predictive of treatment success. Here we assessed whether baseline vaginal soluble immune factors or the composition of the vaginal microbiota predicted treatment success 1 month after metronidazole treatment in 2 separate cohorts of women with BV, 1 in the United States and 1 in Kenya; samples within 48 hours of BV treatment were also available for the US cohort. Neither soluble immune factors nor the composition of the vaginal microbiota before BV treatment was associated with treatment response in either cohort. In the US cohort, although the absolute abundances of key vaginal bacterial taxa pretreatment were not associated with treatment response, participants with sustained BV clearance had a more pronounced reduction in the absolute abundance of Gardnerella vaginalis immediately after treatment. Pretreatment immune and microbial parameters were not predictive of BV treatment success in these clinical cohorts.

Exploring the Efficacy of ZB-06 Vaginal Biofilm as a Novel Treatment for Recurrent Bacterial Vaginosis.

The purpose of this research was to investigate the efficacy of ZB-06 vaginal biofilm as a novel treatment for recurrent bacterial vaginosis (BV). BV is a prevalent vaginal infection that primarily affects women of reproductive age and is linked to adverse health outcomes. Biofilm production allows bacteria to cling to the vaginal epithelium, making antibiotics harder to penetrate and treat the illness efficiently. ZB-06 is a vaginal biofilm inhibitor that may dissolve the biofilm generated by the bacteria causing BV, enhancing antibiotic therapy efficacy and lowering the risk of recurrence. The current literature on BV, biofilm formation, and the possible function of ZB-06 as a therapy option for recurrent BV is reviewed in this article. More research is needed to determine ZB-06's safety and efficacy.

Подход к лечению бактериального вагиноза с применением комплекса бактериофагов

Introduction. A variety of treatment regimens for bacterial vaginosis (BV) pose to the clinician the question of choosing appropriate therapy for this disease. Aim. Improving the results of combination treatment of reproductive-age women with bacterial vaginosis by topical application of polyvalent bacteriophages. Materials and methods. A prospective study involving 120 female patients from 18 to 45 years old with complaints of abnormal vaginal discharge, diagnosis of BV confirmed by the Amsel criteria was performed. The patients were divided into 4 groups of 30 people, depending on the treatment regimen for BV: group 1 – metronidazole (gel) intravaginally + preparation Phagogyn (gel), polyvalent bacteriophage (PVB) for topical application; group 2 – clindamycin (cream) intravaginally + Phagogyn for topical application; group 3 – chlorhexidine gluconate (vaginal tablets) + Phagogyn for topical application; group 4 – Elzhina (ornidazole 500 mg, neomycin 65 000 U, prednisolone 3 mg, econazole 100 mg) + Phagogyn for topical application. Results. 10–14 days after the treatment, the effectiveness of metronidazole for vaginal application in combination with Phagogyn according to the Amsel criteria was 60.00%, clindamycin intravaginally in combination with Phagogyn – 73.33%, chlorhexidine gluconate intravaginally with Phagogyn – 43.33%, Elzhina + Phagogyn – 96.67%. Conclusion. The combination of Elzhina with Phagogyn is feasible for use in clinical practice to achieve better results in the treatment of BV, since this combination turned out to be the most effective.