DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy

NCT ID: NCT06397248

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-22
• Study Completion Date: 2025-05-31

Brief 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.

Conditions

Vulvovaginal Candidiasis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Healthy women

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

No intervention

Intervention Type: OTHER

No intervention

Women with an acute episode of vulvovaginal candidiasis

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.

No intervention

Intervention Type: OTHER

No intervention

Women that suffer from recurrent episodes of vulvovaginal candidiasis

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

No intervention

Intervention Type: OTHER

No intervention

Interventions

No intervention

No intervention

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute

OTHER

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Lebeer, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

Femicare vzw

Tienen, Vlaams-Brabant, Belgium

Site Status: RECRUITING

University of Antwerp

Antwerp, , Belgium

Site Status: RECRUITING

University of Antwerp

Antwerp, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Gilbert Donders, Professor

Role: CONTACT

gilbert.donders@femicare.net

+3216 80 81 02

Veronique Verhoeven, Professor

Role: CONTACT

veronique.verhoeven@uantwerpen.be

+3232652518

Facility Contacts

Gilbert Donders, Professor

Role: primary

gilbert.donders@femicare.net

+3216808102

Charlene Caparino

Role: backup

charlene.caparino@femicare.net

Sarah Lebeer, Professor

Role: primary

sarah.lebeer@uantwerpen.be

+32 3 265 32 85

Maline Victor, MSc

Role: backup

maline.victor@uantwerpen.be

+32493505645

Veronique Verhoeven, Professor

Role: primary

veronique.verhoeven@uantwerpen.be

+3232652518

Other Identifiers

S006424N

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

5863

Identifier Type: OTHER

Identifier Source: secondary_id

EDGE 003471

Identifier Type: -

Identifier Source: org_study_id