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Vaginosis, Bacterial clinical trials

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NCT ID: NCT06263465 Recruiting - Bacterial Vaginosis Clinical Trials

Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis

Start date: March 11, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06228469 Not yet recruiting - Cytolytic Vaginosis Clinical Trials

Cytolytic Vaginosis Multicentre Registry

Start date: March 1, 2024
Phase:
Study type: Observational

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?

NCT ID: NCT06154239 Recruiting - Bacterial Vaginosis Clinical Trials

Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views

STAMP
Start date: January 2024
Phase: N/A
Study type: Interventional

Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).

NCT ID: NCT06135974 Recruiting - Bacterial Vaginosis Clinical Trials

Vaginal lIve Biotherapeutic RANdomized Trial

VIBRANT
Start date: October 19, 2023
Phase: Early Phase 1
Study type: Interventional

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.

NCT ID: NCT06131749 Active, not recruiting - HIV Infections Clinical Trials

Genital Tract Infections, the Vaginal Microbiome and Gestational Age at Birth Among Pregnant Women in South Africa

Start date: March 1, 2021
Phase:
Study type: Observational

This cohort study plans to investigate associations between the presence of multiple lower genital tract microorganisms in pregnancy and gestational age at birth. The study enrols pregnant women at one public health care facility in East London, South Africa. At enrolment and 30-34 weeks of pregnancy, participants provide swabs for testing for sexually transmitted infections, vaginal yeasts and genital mycoplasmas; for microscopy and Nugent scoring; and for 16S ribosomal ribonucleic acid gene sequencing and quantification. The primary outcome is gestational age at birth. Statistical analyses include: regression modelling to explore associations between specific microorganisms (including microbiota) and gestational age at birth; construction of an index of vaginal inflammation, using data about microorganism load and inflammatory potential; classification and regression tree analysis to examine which combinations of microorganisms contribute to earlier gestational age at birth.

NCT ID: NCT06123299 Recruiting - Bacterial Vaginosis Clinical Trials

A Randomised, Partly-blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Bacterial Vaginosis Compared With an Untreated Control Group

Nefertiti 2
Start date: November 20, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06104098 Completed - Bacterial Vaginoses Clinical Trials

A User Study With Vernivia® for Bacterial Vaginosis.

USV01
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

This is an open user study to evaluate D005 vagnial mousse with regards to user-friendliness, and measure time from start of treatment to symptom relief and measure the clarity of instructional material. The study will be conducted at seven sites in Sweden, the study population will consist of up to 100 female subjects.

NCT ID: NCT06069531 Recruiting - Vaginitis Bacterial Clinical Trials

Effect of Lactobacillus Johnsonii or White Pomegranate Extract on the Vaginal Health

Start date: October 2, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to explore the effect of Lactobacillus johnsonii and white pomegranate extract on female bacterial status, it aims to answer are: - Evaluate Lactobacillus johnsonii TCI250 probiotics or white pomegranate extract in regulating female vaginal bacteria and improving vaginal health. - Evaluate Lactobacillus johnsonii TCI250 probiotics or white pomegranate extract in regulating inflammation. Participants will be randomly assigned to placebo (n = 50), probiotic heat-killed Lactobacillus johnsonii TCI250 group (n = 50) and white pomegranate extract group (n = 50) for 8 weeks. Researchers will compare the vaginal flora and inflammation.

NCT ID: NCT06056947 Completed - Bacterial Vaginosis Clinical Trials

Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule

One-Shot
Start date: July 20, 2020
Phase: Phase 3
Study type: Interventional

Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.

NCT ID: NCT05963711 Recruiting - Clinical trials for Microbial Colonization

The Genital Microbiome of Male Partners of Women With Recurrent BV Undergoing Vaginal Microbiome Transplantation

Start date: October 17, 2022
Phase: N/A
Study type: Interventional

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.