DeVEnIR: Defining Vulvovaginal Candidiasis

Status Recruiting

Clinical Trial Summary

Female-specific health conditions are underrepresented in research. The taboo felt by women to talk about intimate wellbeing is fed by this gender gap in scientific knowledge. This project aims to meet these needs by studying one of the most prevalent female-specific infections, vulvovaginal candidiasis (VVC), and paving the way towards its efficient diagnosis and treatment. About 70% of women worldwide suffer from vaginal candidiasis at least once in their life. An episode of this fungal infection is accompanied by a burning sensation, pain, and reduced mental well-being. Some women (about 5%) encounter such infections at least four times a year, referring to recurrent(R) VVC. The design of efficient diagnostic and therapeutic strategies for (R)VVC is hindered by a knowledge gap surrounding vaginal health. To meet the absolute need for more information, this project will characterize the role of the microbiome, metabolome, immune system, and pathogen characteristics in (R)VVC. To this end, a large sampling platform of women with/without VVC will be established in this project. The researchers will identify the most important and clinically relevant microorganisms, metabolites, and immune factors in VVC pathogenesis. VVC models will be developed and optimized, which will be used to validate the causality of the correlations identified in the cohort. Identified correlations will be proposed as biomarkers, and microbes, metabolites, and combinations, which effectively lower the pathogenicity of Candida species, will be further investigated for therapeutic potential. State-of-the-art tools and know-how of the researchers will allow the unraveling of the involved molecular pathways and elucidate how these can be exploited to optimize therapeutic efficacy. Finally, the knowledge gathered in this project will be used to improve the literacy of women on VVC using platforms established by the researchers as well as novel tools to be developed in this project.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06397248
Study type	Observational
Source	University Hospital, Antwerp
Contact	Gilbert Donders, Professor
Phone	+3216 80 81 02
Email	gilbert.donders@femicare.net
Status	Recruiting
Phase
Start date	May 22, 2024
Completion date	May 2025

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See also
Status	Clinical Trial	Phase
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Completed	`NCT02150655` - Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women	Phase 0
Completed	`NCT00755053` - Comparative Efficacy of Ovule vs Tablet	Phase 3
Completed	`NCT02679456` - Safety and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Oral Fluconazole in Subjects With Vulvovaginal Candidiasis	Phase 2
Completed	`NCT02242695` - Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis	Phase 4
Completed	`NCT00895453` - Monthly Itraconazole Versus Classic Homeopathy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC)	N/A
Completed	`NCT05327192` - VVC Sampling Study for Analysis Validation
Completed	`NCT05399641` - Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis	Phase 3
Completed	`NCT01806623` - The Study Of Fluconazole For Vulvovaginal Candidiasis	Phase 3
Recruiting	`NCT05079711` - Comparative Performance of a Vaginal Yeast Test
Completed	`NCT05507333` - Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis	N/A
Completed	`NCT01144286` - Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment	Phase 2
Completed	`NCT00353561` - Diabetes Mellitus and Vulvovaginal Candidiasis	Phase 3
Recruiting	`NCT05895162` - Zinc-containing Vaginal Gel and Oral Fluconazole for Vulvovaginal Candidiasis.	N/A
Not yet recruiting	`NCT06450990` - Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection	Phase 1/Phase 2
Recruiting	`NCT05908682` - Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Completed	`NCT02203942` - Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis	N/A
Completed	`NCT01926028` - Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis	Phase 1/Phase 2
Completed	`NCT00194324` - Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina	Phase 4
Completed	`NCT02866227` - TOL-463 Phase 2 Study for Vaginitis	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy — DeVEnIR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms