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Candidiasis, Vulvovaginal clinical trials

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NCT ID: NCT04930107 Recruiting - Clinical trials for Candidiasis, Vulvovaginal

Vulvovaginal Candidiasis in Canadian Females

THRIVE-yeast
Start date: December 7, 2021
Phase: Early Phase 1
Study type: Interventional

Vulvovaginal candidiasis (VVC; colloquially referred to as a 'yeast infection') is a prevalent mucosal infection caused by Candida spp. that affects ~75% of women at least once in their life. VVC usually responds well to treatment, yet a small but significant fraction of women experience recurrent yeast infections even with weekly treatment. A further complication in understanding the causes of recurrent infections is that approximately one in five females have vaginal yeast present without any symptoms at any given point. The link between fungi, other microbes in the vagina ("microbiome"), and the human immune system remain poorly understood in the switch from having yeast present in the vagina without any symptoms and symptomatic yeast infections. Fungi also compose a normal component of the microbiome at other sites in the body (e.g., oral, skin, gastrointestinal tract, rectum) where they may serve as a source of re-infection following treatment. In addition to the commonly prescribed 'first choice' antifungal drug fluconazole, a second-line treatment, boric acid, has shown promise in the literature and has been used locally with success at increasing the time between recurrent infections. A drawback of this therapy, however, is cost, as it is a compounded medication, and patients have to pay out of pocket. The purpose of this study is to understand how the yeast and bacterial microbial communities differ for females with recurrent infections from females with their first yeast infection and females with vaginal yeast present without any symptoms, and to track yeast diversity following treatment with either boric acid or fluconazole. The investigators hypothesize that they will identify multiple subpopulations of yeast at multiple anatomical body sites in females with VVC and recurrent VVC. They anticipate finding evidence for recurrent infection from secondary sites by linking genomic diversity of vaginal yeast strains during symptomatic infection to strains from other body sites. They hypothesize that yeast isolated from females with recurrent infections will exhibit different drug response phenotypes than yeast from females with asymptomatic vaginal yeast. They hypothesize that the vaginal microbiome of post-treatment patients treated with boric acid will differ from that of fluconazole. Combined, they hypothesize that post-treatment response will differ between the drugs, indicating that treatment specifics influence the vaginal environment.

NCT ID: NCT04813822 Recruiting - Clinical trials for Acute Vulvovaginal Candidiasis

Study Evaluating the Efficacy and Safety of Miconazole Nitrate + Domiphen Bromide Vaginal Cream in the Treatment of Subjects With Acute Vulvovaginal Candidiasis

Start date: September 13, 2021
Phase: Phase 2
Study type: Interventional

This study is a multicentre, three-arm, double-blind, randomized controlled, parallel-group, comparative phase II clinical trial to evaluate miconazole nitrate 2% + domiphen bromide vaginal cream in subjects with acute vulvovaginal candidiasis.

NCT ID: NCT04699240 Recruiting - Clinical trials for Recurrent Vulvovaginal Candidiasis

Study of Lactobacillus in Adjuvant Treatment of RVVC

Start date: July 1, 2020
Phase: Phase 4
Study type: Interventional

We are trying to determine if Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis

NCT ID: NCT04552210 Recruiting - Infection Clinical Trials

Mannose Binding Lectin Gene Polymorphism Versus Microbial Virulence in the Pathogenesis of Vulvovaginal Candidiasis

Start date: September 16, 2020
Phase:
Study type: Observational

The vaginal mucosa is inhabited by both fungal and bacterial microorganisms which normally co-exist with the host in a tightly regulated and commensal manner.

NCT ID: NCT04292704 Recruiting - Laser Therapy Clinical Trials

A Protocol for the Role of Fractional CO2 Laser in Consolidation Treatment of Recurrent Vulvovaginal Candidiasis

Start date: December 13, 2019
Phase: N/A
Study type: Interventional

Background: Recurrent vulvovaginal candidiasis (RVVC) is a common obstinate vulvovaginal inflammation in gynecology. At present, the pathogenesis of RVVC is not clear. In recent years, it is emphasized that the changes of vaginal microecological environment play an important role in the occurrence and development of RVVC. The treatment of RVVC can be divided into intensive treatment and consolidation treatment. Currently, local antifungal treatment is the main treatment regimen. While it is difficult and had an insufficient effect on prevention from recurrence of clinical signs and the improvement of vaginal mycological status in long term. Besides, there is no mature consolidation treatment regimen at home and abroad. Through the current application of the fractional CO2 laser in the treatment of atrophic vaginitis, it is confirmed that local irradiation of the fractional CO2 laser on vulva and vagina can regenerate and repair mucosal tissue, enhance the function of vaginal epithelial cells, gradually restore the normal pH value of vagina, improve vaginal microecological environment, restore the proportion of vaginal flora and reduce the recurrence rate of RVVC. This trial aims to explore the efficacy of two consolidation therapy schemes: the fractional CO2 laser and traditional antifungal drugs. Methods/Design: The ongoing study will include 200 RVVC patients who voluntarily joined the study and signed the informed consent form the Second Affiliated Hospital of WMU during December 2019 to March 2022. After patients were cured by transvaginal local drug intensive therapy, participants will be randomly divided into control group (n = 100) and experimental group (n = 100). The control group continue to receive a monthly course of vaginal local drug consolidation therapy for 6 months, while the experimental group will be given monthly local vaginal CO2 laser consolidation therapy for 3 months. The vaginal secretions samples of RVVC patients will be collected before intensive therapy, after intensive therapy and at the end of consolidation therapy, and the species abundance and structure of vaginal flora were detected and analyzed. In the same period, 5 healthy women of childbearing age were recruited as the normal control group and the volunteers do not take any treatment. The vaginal secretions samples of 5 volunteers will be collected when signing the informed consent to detect and analyze the species abundance and structure of vaginal flora. The patients with RVVC will be followed up for 3, 6 and 12 months after the treatment and vaginal secretions samples will be collected for vaginal flora structure detection to compare the vaginal microecological environment. For recurrent patients, the investigators will carry out targeted treatment, and again collect vaginal secretions sample to detect and analyze the species abundance and structure of vaginal flora. Objectives: The aim of this study is to compare the effects of fractional CO2 laser consolidation therapy and traditional antifungal consolidation therapy for RVVC, and assess the role of fractional CO2 laser in changes of vaginal microecological environment and recurrence rate of VVC after consolidation treatment.

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: NCT03075046 Recruiting - Clinical trials for Candidiasis, Vulvovaginal

Use of 405nm Blue Light Emitting Diode in the Treatment of Women With Vulvovaginal Candidiasis: a Clinical Trial

Start date: April 20, 2017
Phase: N/A
Study type: Interventional

Vulvovaginal candidiasis (CVV) is an infectious process of the female genitourinary tract, an important health issue due to the high incidence and difficulties encountered in the treatment. Therefore, new therapeutic modalities are sought with the capacity to minimize drug side-effects and to reduce recurrent cases. The objective of this stufy is to evaluate the clinical and microbiological response of the 405 nm blue light emitting diode in the treatment of women with vulvovaginal candidiasis and in women with healthy gentourine treatment. A clinical trial was conducted involving 40 women, divided into two groups, the first group consisting of women with a confirmed CVV diagnosis and a second group formed by women with a healthy genitourinary tract, without symptoms and symptoms of the disease. Both groups underwent clinical evaluation and examination with endocervice collection with gynecologist before and after a session of application of the Blue Light Emitting Diode of 405 nm, lasting 4.5 minutes. There will also be an evaluation of the effects of the diary through the questionnaire answered before and after the participants' treatment. It is expected that the 405 nm blue LED will destroy the CVV fungus demonstrated by laboratory examination and also improve the signs and results analyzed by the gynecologist and participants.

NCT ID: NCT03024502 Recruiting - Clinical trials for Vulvovaginal Candidiasis

Patients With Vulvovaginal Candidiasis

EPP-AFG-VVC
Start date: January 30, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The present study aims to evaluate the safety of two mucoadhesive gels containing a propolis standardized extract identified as EPP-AF, with 1 and 2% of propolis. The efficacy studies with both propolis gels will be performed in comparison with clotrimazole cream in patients presenting vulvovaginal candidiasis.