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DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy

NCT06397248 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-05-28

No results posted yet for this 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.

Conditions

  • Vulvovaginal Candidiasis

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

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

    collaborator OTHER

  • Universiteit Antwerpen

    collaborator OTHER

  • Research Foundation Flanders

    collaborator OTHER

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Sarah Lebeer, Prof. · Universiteit Antwerpen

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-22
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06397248 on ClinicalTrials.gov