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Bacterial Vaginosis clinical trials

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NCT ID: NCT05753813 Recruiting - Bacterial Vaginosis Clinical Trials

Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome

Start date: February 27, 2023
Phase: Early Phase 1
Study type: Interventional

This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.

NCT ID: NCT05701722 Completed - Bacterial Vaginosis Clinical Trials

Effect of Flourish HEC Vaginal Care System on BV Recurrence and the Vaginal Microbiome

Start date: March 29, 2023
Phase: N/A
Study type: Interventional

The 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.

NCT ID: NCT05666778 Recruiting - Bacterial Vaginosis Clinical Trials

Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs

POWWERHealth
Start date: February 13, 2023
Phase: Phase 2
Study type: Interventional

HIV 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.

NCT ID: NCT05652959 Completed - Bacterial Vaginosis Clinical Trials

Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis

Start date: May 20, 2021
Phase:
Study type: Observational

Vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora. The most prevalent is bacterial vaginosis, followed by other clinical entities such as candidiasis, trichomoniasis and non-specific vaginitis. A collection of clinical data was conducted to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vaginitis in clinical practice. A total of 111 women aged between 20 and 70 years were recruited, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with antibiotic therapy. The aim of our study was to assess the relief in vaginal symptoms and changes in the normal vaginal pH level after 3 months of treatment with Cerviron® medical device in real-life clinical practice settings.

NCT ID: NCT05590195 Not yet recruiting - Clinical trials for Bacterial Infections

Effect of PreforPro® on Urinary and Vaginal Health

Start date: May 1, 2024
Phase: Phase 3
Study type: Interventional

This study will investigate the effects of PreforPro® (prebiotic and bacteriophages (LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae, greater > 6.7 X 107 PFU/gram) on bacterial vaginosis.

NCT ID: NCT05587283 Recruiting - Clinical trials for Bacterial Infections

Safety, Tolerability, and Acceptability Study of Intravaginal Administration of LABTHERA-001 Capsules in Healthy Women

Start date: November 2, 2022
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT05434104 Not yet recruiting - Bacterial Vaginosis Clinical Trials

The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study

LISA
Start date: October 2022
Phase: N/A
Study type: Interventional

Three-quarters of women have bacterial vaginosis (BV) or vaginal thrush/candida yeast infection at least once during their lifetime. Symptoms can include abnormal vaginal discharge, soreness, itching and an unpleasant smell. BV during pregnancy can make the baby come too early. In the UK over a million women suffer recurrent vaginal infections. These can affect their sexual relationships and quality of life, and may need repeated courses of treatment. But some women prefer not to keep taking antibiotics which can have side effects and encourage the growth of resistant superbugs. Lactoferrin is a prebiotic protein derived from cow's milk. Women also have naturally occurring lactoferrin in their vagina where it helps to prevent infections and encourage the growth of healthy bacteria. Recent research suggests lactoferrin may be an effective treatment for BV and thrush, but this needs to be confirmed. Aim To see if it is feasible to conduct a future trial to prove whether lactoferrin vaginal pessaries are an acceptable, effective and cost-effective alternative to antibiotic tablets for women with BV or thrush. Methods The investigators will recruit a total of 57 women with BV and 57 with thrush from two sexual health clinics and a general practice. Women will be asked to provide self-taken vaginal samples with a cotton bud, and to complete a confidential sexual-health questionnaire. Then the women will be divided into two groups. One group will be given lactoferrin vaginal pessaries to use every night for 3-weeks. The other group will be given antibiotic/antifungal tablets. All women will be asked to provide repeat vaginal samples at home and text us about any symptoms to see if the treatment works, if the infection comes back and if they would like antibiotics. After 12-weeks all women will be invited back for a final check-up. Outcome measures: - Acceptability and use of vaginal lactoferrin - from questionnaires, and interviews with 15-20 women - Recruitment and follow-up rates - Cost of lactoferrin treatment - The percentage of women who report their symptoms have resolved after a week - How quickly infections clear or recur - from analysis of samples Patient benefit: If this study leads to a trial showing vaginal lactoferrin is an acceptable and effective alternative to antibiotics, this could help relieve symptoms, prevent antimicrobial resistance and save NHS costs.

NCT ID: NCT05386147 Completed - Bacterial Vaginosis Clinical Trials

Flourish HEC to Prevent Recurrence of BV

Start date: December 22, 2021
Phase: N/A
Study type: Interventional

In a population of women with heightened vulvovaginal sensitivity and recurrent bacterial vaginosis (BV), the use of the Flourish HEC Vaginal Care System is being tested for prevention of BV recurrence over six months of use.

NCT ID: NCT05354050 Completed - Bacterial Vaginosis Clinical Trials

Pharmacokinetic Study of DARE-BV1

Start date: November 3, 2020
Phase: Phase 1
Study type: Interventional

Single-Center, Phase 1, Single-dose PK study of DARE-BV1 (2% clindamycin phosphate vaginal gel, 100mg) under development for the treatment of bacterial vaginosis (BV).

NCT ID: NCT05340790 Recruiting - Bacterial Vaginosis Clinical Trials

First in Human Study in Healthy Volunteers of Antimicrobial Peptide PL-18 Vaginal Suppositories

Start date: August 1, 2022
Phase: Phase 1
Study type: Interventional

This is a Single-center, Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability and PK Profiles of Single and Multiple Ascending Doses of Antimicrobial Peptide PL-18 Vaginal Suppositories.