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Vaginosis, Bacterial clinical trials

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NCT ID: NCT04287504 Recruiting - Preterm Birth Clinical Trials

Point-of-care Tests for Bacterial Vaginosis and Candidosis

Start date: February 14, 2020
Phase:
Study type: Observational

Vaginal infection in early pregnancy is associated with an increased risk of spontaneous preterm delivery and late miscarriage. Most studies presume that vaginal infections are responsible for up to 40% of preterm birth. Although the causative microorganisms of vaginal infections are manifold, the three pathogens most commonly associated with vaginal infections are Gardnerella vaginalis, Candida albicans and Trichomonas vaginalis. The aim of this prospective study is the validation of the point-of-care tests OSOM BVBLUE for bacterial vaginosis and SavvyCheck Vaginal Yeast Test for candidosis in comparison to Gram stain.

NCT ID: NCT04219605 Recruiting - Bacterial Vaginosis Clinical Trials

Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

Start date: December 1, 2020
Phase:
Study type: Observational

Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.

NCT ID: NCT04046900 Recruiting - Clinical trials for Recurrent Bacterial Vaginosis

Vaginal Microbiota Transplant

MOTIF
Start date: April 22, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized trial of vaginal microbiome transplant vs. saline placebo to restore a Lactobacillus dominant vaginal microbial community in women with recurrent bacterial vaginosis.

NCT ID: NCT03500107 Recruiting - Clinical trials for Vaginosis, Bacterial

Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical Trial

Start date: October 2, 2018
Phase: N/A
Study type: Interventional

Bacterial 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.

NCT ID: NCT03446443 Recruiting - Bacterial Vaginitis Clinical Trials

Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

Start date: July 26, 2018
Phase: Phase 4
Study type: Interventional

This is a Randomized, Positive -Controlled, Multi-center Trial enrolling 240 subjects with Bacterial Vaginosis who will be randomized at a ratio of 1:1 to receive active Honghe Fujie lotion or Metronidazole Suppositories. The primary objective is to assess the safety and tolerability of Honghe Fujie lotion compared to Metronidazole Suppositories.

NCT ID: NCT03357666 Recruiting - Bacterial Vaginosis Clinical Trials

Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis

Start date: March 22, 2016
Phase: Phase 2
Study type: Interventional

The objective of the study is to confirm the pharmacological mechanism and evaluate the efficacy and safety after HUDC-VT administration compared to placebo in patients with bacterial vaginosis. Vaginitis in adult women is extremely common and it often results in marked suffering. Epidemiologic studies indicate the high prevalence of vaginitis and the large number of causes in US. The broad-spectrum antibiotics such as metronidazole have been used as a treatment of vaginitis.However, it is not desirable using of these antibiotics caused appearance of resistant bacterium and killing normal bacterium including lactobacillus. In addition, it has been reported that long term treatment of antibiotics can be caused body toxicity through absolution by vagina. The product, HUDC_VT, is a effective and safe vaginal tablet composed glucose and sodium chloride for treatment of vaginitis by preserving healthy condition in vagina.

NCT ID: NCT03234517 Recruiting - Clinical trials for Bacterial Vaginosis Treatment

Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis

Start date: August 1, 2016
Phase: Phase 2
Study type: Interventional

Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis

NCT ID: NCT03080740 Recruiting - Bacterial Vaginosis Clinical Trials

The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis

Start date: July 2016
Phase: Phase 4
Study type: Interventional

Randomized, double blind, positive drug parallel comparison, multi-centre clinical trial to assess the Efficacy and Safety of Clindamycin palmitate hydrochloride dispersible tablet for the treatment of bacterial vaginosis

NCT ID: NCT02185456 Recruiting - Bacterial Vaginosis Clinical Trials

Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis

BV-LbRC
Start date: September 2014
Phase: Phase 0
Study type: Interventional

Bacterial vaginosis (BV) is the commonest form of vaginitis worldwide, affecting millions of women. Unfortunately, recurrence rates of symptomatic BV remain extremely high, 30% at three months and 70-80% within a year. Given the paucity of information and data regarding pathogenesis of BV, the etiopathogenesis of recurrent bacterial vaginosis remains unknown. Accordingly, reliable, proven treatment regimens for Recurrent Bacterial Vaginosis (RBV) are not available. In 2013, the investigators published two manuscripts documenting a new qPCR based approach to BV diagnosis and potentially prognosis. The method (LbRC) measures the content of lactobacilli in vaginal samples, relative to total bacterial load. The first goal of this study are to validate that this metric is a reliable diagnostic of BV, by determining sensitivities and specificities relative to Nugent scores and Amsel criteria of healthy women and BV patients. A high LbRC score (3-4) corresponds to a healthy state. The second goal is to determine whether empirically determined "low" LbRC scores (1-2) in BV patients after treatment are indicators of recurrence, and whether preemptive action, based on this score, with more intensive treatment, delays or eliminates recurrence in these patients.

NCT ID: NCT02173184 Recruiting - Bacterial Vaginosis Clinical Trials

Safety and Efficacy Study of Gynevac Lactobacillus Vaccine in the Treatment of Bacterial Vaginosis

Start date: June 2014
Phase: Phase 3
Study type: Interventional

To investigate the efficacy (therapeutic response) of Gynevac vaccination following a 5-shot treatment period in patients with bacterial vaginosis, based on the Nugent Score and the Amsel criteria