View clinical trials related to Vaginal Diseases.
Filter by:The purpose of this clinical trial is to study the efficacy of bovgialuronidase azoximere in the treatment and duration of recurrence-free course of bacterial vaginosis in women of reproductive age. The main questions it aims to answer are: - Is bovgialuronidase azoximer able to destroy G. vaginalis associated biofilms of the vaginal epithelium - use of bovgialuronidase azoximer together with Metronidazole increases the effectiveness of treatment of bacterial vaginosis. - use of azoximers bovgialuronidase together with Metronidazole increases the duration of relapse-free course of bacterial vaginosis. Participants in the experimental and control group will be: - Amsel criteria assessment - Colpotest-PH (vaginal acidity) - aminotest with 10% KOH solution ("fish odor") - microscopic examination of vaginal discharge - Bacteriologic culture of vaginal discharge - Polymerase chain reaction of epithelial cell scrapings from the vagina - electron microscopy of vaginal epithelial cell scrapings Participants in the main group will be given the drug Bovgialuronidase azoximer and Metronidazole. Participants in the control group: Metronidazole. Researchers will compare the experimental and control groups to see if there are differences after treatment in biofilm structure, treatment efficacy, and duration of recurrence-free survival.
Bacterial vaginosis (BV) occupies one of the leading places in the structure of the of gynecologic morbidity. This syndrome affects from 26 to 29% of women of reproductive age. Bacterial vaginosis is a non-inflammatory syndrome based on the replacement of normal lactoflora by opportunistic microorganisms. The modern concept of pathogenesis of bacterial vaginosis is the formation of biofilms, mainly Gardnerella vaginalis, on the surface of the vaginal epithelium. Associated with biofilms bacterial vaginosis is characterized by increased resistance to pathogenetic therapy, ability to evade protective mechanisms and prolonged persistence in the vaginal environment, which is manifested by an increase in the rate of recurrent and chronic course. In connection with the above described, it is relevant to study in vivo the role of drug action on biofilms in order to destroy them and, as a consequence, to increase the effectiveness of pathogenetic antibacterial therapy, reduce the frequency of BV recurrences and improve the quality of life of women. According to the local and international literature, there are various ways to affect biofilms, one of which is enzymatic destruction of the matrix. Bovgialuronidase azoximer was chosen as the study drug.
The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis.
The goal of this registry is to learn more about cytolytic vaginosis, a little known and controversial condition. The main questions the registry aims to answer are: - What are risk factors of cytolytic vaginosis? - Are there defining symptoms of cytolytic vaginosis? - What features on wet mount should be used to diagnosis cytolytic vaginosis? - Are baking soda vaginal irrigations an effective treatment for cytolytic vaginosis? - Do characteristics of cytolytic vaginosis vary between sites/countries?
The goal of this randomized clinical trial is to evaluate safety and biologic effect of a multi-strain vaginal L. crispatus live biotherapeutic product (LBP) in people receiving antibiotic treatment for bacterial vaginosis (BV). The main question[s] it aims to answer are whether the intervention is safe, and whether the strains of L. crispatus will colonize recipients' vagina. The study will evaluate one LBP with 6 strains of L. crispatus (LC106) and one LBP with 15 strains (LC115) vs. placebo. Participants will: - be treated with oral antibiotics for BV - receive 7 days of vaginal study product - collect daily home swabs and make short daily diary entries for 5 weeks, including the week of antibiotic treatment and the week of study product treatment. Researchers will compare the 3 groups receiving different dosing strategies of LC106 and 1 group receiving LC115 vs. 1 group receiving placebo to see if the live biotherapeutic strains colonize the vagina after antibiotic treatment for BV.
This is a randomised, parallel group, partly blinded investigation to evaluate the clinical performance and safety of pHyph in adult women with bacterial vaginosis. Patients will be randomised to active treatment or no treatment (untreated controls) in a 1:1 ratio. The Investigators carrying out the gynaecological assessments will be blinded. Patients will not be blinded. The population of this investigation will consist of post-menarchal, pre-menopausal females 18 years or older seeking treatment for BV symptoms ("fishy smell", irritation and burning). Approximately 82-92 patients will be recruited and randomised. BV will be diagnosed according to Amsel's criteria, defined as having at least 3 of the 4 criteria. Active treatment (from the start of the investigation) will be compared to no treatment at day 7 after screening (primary endpoint). Clinical cure rate on Day 7 is defined as the absence of all of the following 3 Amsel criteria: - Thin, white, yellow, homogeneous discharge. - Clue cells on microscopy (>20% of epithelial cells). - Release of a "fishy odour", i.e., a positive "whiff test" when alkali (10% KOH solution) is added. Patients receiving rescue treatment before Day 7 will be considered as treatment failures. Patients in the "no treatment group" will receive pHyph as rescue treatment if they are not cured day 7. They will thereafter follow the same scheme as the patients starting with pHyph treatment. After the initial pHyph treatment, daily during 6 days, patients will continue with pHyph twice weekly until day 25 when an additional assessment will be performed. If the patients are cured, they will continue to receive pHyph as preventive treatment during 6 weeks and possible BV recurrences will be assessed.
There is strong observational evidence that sexual activity plays a key role in Bacterial Vaginosis (BV) acquisition and recurrence. Microbiological data support the contribution of sexual transmission to the pathogenesis of BV through the exchange of BV-associated bacteria (BVAB) between sexual partners. Although BV epidemiology strongly suggests sexual transmission, treatment of sexual partners is not recommended, based on prior treatment studies of male partners of women with recurrent BV, which showed no benefit with male treatment. Nevertheless, male condom use is highly protective against recurrent BV. This study aims to evaluate the male-partner's genital microbiome as a potential source of BV-recurrence in women undergoing vaginal microbiota transplantation (NCT04517487), and whether disinfection can eliminate BV-associated penile microbiome.
lactoferrin is believed to modulate immunity and help in prevention of recurrent bacterial vaginosis.In this study, the role of lactoferrin is assessed during third trimester of pregnancy.
This is a phase 1, Single-Center, Double-Blind, Randomized, Placebo-Controlled, dose escalation, clinical trial enrolling 24 healthy participants. The main subject is to investigate the safety and tolerability of the LABTHERA-001 capsule and to explore the acceptability of the capsule.
The purpose of this investigator-initiated randomized control trial is to determine if bacterial vaginosis infection increases the likelihood of preterm delivery in women with history of preterm delivery. Subjects will be randomized in a two-arm study to undergo predetermined intervals of testing for bacterial vaginosis or control.