DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy

Antwerp University Hospital (UZA)

Status: Enrolling

Conditions: Vulvovaginal Candidiasis

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06397248

S006424N (Other Grant/Funding Number)

EDGE 003471

5863

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• Age: 18-50
• Premenopausal

Exclusion criteria

• Pregnancy
• Self-reported vaginal complaints (e.g. redness, itching, pain, burning sensation, abnormal vaginal discharge) in the past 12 months (only for healthy group)
• Use of antibiotics/antifungals in the month prior to sample collection (only for healthy group)

Trial design

500 participants in 3 patient groups

Healthy women

Description:

Healthy volunteers that do not have vaginal complaints or symptoms, and did not have any in the past 12 months.

Treatment:

Other: No intervention

Women with an acute episode of vulvovaginal candidiasis

Description:

Women that have sporadic/acute vulvovaginal Candida infection. It's the first time or the first time in a longer period (1-2 years) that these women have an infection.

Treatment:

Other: No intervention

Women that suffer from recurrent episodes of vulvovaginal candidiasis

Description:

These women encounter such infections at least 3 times a year. These women are targeted both during an infection and in between infections.

Treatment:

Other: No intervention