Role of Oral Lactoferrin in Prevention of Recurnt Bacterial Vaginosis in Pregnancy
Bacterial Vaginosis | Vaginal | Microbiologylactoferrin 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.
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial VaginosesThis is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control. Treatment arm 1: Multi-Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi-Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.
Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical...
VaginosisBacterialBacterial Vaginosis (BV) is a infectious process of the female genitourinary tract, an important health issue due to the high incidence and high rate of recurrence of the infection. Therefore, new therapeutic modalities are sought with the capacity to minimize drug side effects and reduce cases of recurrence of the disease. The objective of this study is to evaluate the clinical and microbiological response of the 401+/- 5nm blue light emitting diode (LED) in the treatment of women with bacterial vaginosis. The group of women with diagnosis of bacterial vaginosis will be submitted to the light therapy. These women will also be submitted to an evaluation and examination by a ginecologist before and after the therapy. There will also be an evaluation of the clinical condition and about the effects of the light through the questionnaire answered before and after participant's treatment. It's expected that the 41 +/- 5nm LED will destroy the VB demonstrated by laboratory examination and also improves the signs and results analyzed by the gynecologist and participants.
A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial...
Bacterial VaginosisThe investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis
Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms...
Vaginal DiseaseThis study evaluates the efficacy and safety of a new hyaluronic acid-based vaginal moisturizer gel to ease symptoms of vaginal dryness compared to a commonly used marketed vaginal moisturizer (Cumluade Hidratante Interno®).
Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis
Bacterial VaginosesVaginal Microbiome Transplantation (VMT) may be beneficial in treating the most severe cases of recurrent and antibiotics-nonresponsive cases of BV. Recently, we completed a preliminary study in which we treated patients with recurrent and antibiotics-non-responsive, intractable BV, with VMT from healthy donors [Lev-Sagie, Nature Medicine 2019]. Four VMT recipients in this preliminary study featured a significant improvement of both clinical symptoms and dysbiotic vaginal microbiome composition and function, which persisted over a long follow-up period, while one recipient featured a partial remission. The proposed study is designed as a placebo, randomized controlled trial, and is aimed to further assess whether VMT may serve as a viable option in symptomatic, intractable BV. In the suggested study, we plan to compare transplantation of: 1) vaginal fluid from healthy donors, and 2) autologous transplantation, of the patient's own vaginal fluid.
Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis...
Bacterial VaginosisVaginal Microbiome3 moreHIV remains a global pandemic with 37 million infected. In western Kenya, 16% of women in the general population and 29% of the poorest women have HIV. The HIV and sexually transmitted infection (STI) epidemics overlap with broader reproductive health concerns. Menstrual hygiene management is a big problem in low- and middle-income countries and a lack of menstrual products negatively impacts women's work-life. This comes from cultural taboos, stigma, and discrimination, promoting secrecy around menstruation, high cost of menstrual products, use of traditional materials (e.g. rags, cotton wool, etc.) causing leakage and odor, and lack of water and safe hygiene facilities. Menstrual cups designed for use during sex may help women prevent Bacterial vaginosis (BV) and STIs through hygienic period practices, and may help them avoid bad practices in an attempt to maintain vaginal dryness. The goal of this interventional trial is to test the impact of menstrual cups on vaginal microbiome, BV, and STIs of poor women at high risk for STIs and HIV. We predict to see 25% less BV, our primary outcome, over one year. This trial aims to learn more about the safety of the intervention, and understand what is needed to fully implement the program.
Effect of Flourish HEC Vaginal Care System on BV Recurrence and the Vaginal Microbiome
Bacterial VaginosisThe goal of this clinical trial is to learn about the vaginal microbiome in premenopausal women with recurrent bacterial vaginosis (BV). The main questions it aims to answer are: Does using a specific vaginal care system reduce recurrence of BV? How does using this vaginal care system change the vaginal microbiome and pH over time? Participants will: Have their vaginal microbiome and pH tested in several ways at three timepoints: the start of the study, 12 weeks later, and 24 weeks after the start of the study Answer questionnaires about vulvovaginal symptoms at each of these three timepoints Use a specific vaginal care system at home for 24 weeks, consisting of an intimate wash, a vaginal moisturizing gel, and a vaginal probiotic suppository, if assigned to the intervention group Researchers will compare the group using the vaginal care system with a control group that does not use the system to see if using the system reduces risk of BV recurrence or changes the vaginal microbiome, pH, or symptoms.
Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules...
Bacterial VaginosisVaginal Disease4 moreThis 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.
Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy...
Vaginal DiseaseRandomized, open-label, national (France), multicenter, prospective clinical study, to evaluate the superiority of Mucogyne® ovules over the control group on vaginal health (including hydration) in women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer.