DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy

Last updated: May 24, 2024
Sponsor: University Hospital, Antwerp
Overall Status: Active - Recruiting

Phase

N/A

Condition

Candidemia/candidiasis

Vaginitis

Gynecological Infections

Treatment

No intervention

Clinical Study ID

NCT06397248
EDGE 003471
5863
S006424N
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female

  • Age: 18-50

  • Premenopausal

Exclusion

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 forhealthy group)

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
May 22, 2024
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Femicare vzw

    Tienen, Vlaams-Brabant 3300
    Belgium

    Active - Recruiting

  • University of Antwerp

    Antwerp, 2020
    Belgium

    Active - Recruiting

  • University of Antwerp

    Antwerpen, 2020
    Belgium

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.