DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy

Vulvovaginal Candidiasis Clinical Trial

— DeVEnIR  

Official title:

DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397248
• Other study ID #: EDGE 003471
• Secondary ID: S006424N5863
• Status: Recruiting
• Start date: May 22, 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Antwerp
• Contact: Gilbert Donders, Professor
• Phone: +3216 80 81 02
• Email: gilbert.donders[@]femicare.net
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Belgium	University of Antwerp	Antwerp
Belgium	University of Antwerp	Antwerpen
Belgium	Femicare vzw	Tienen	Vlaams-Brabant

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Antwerp	KU Leuven, Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute, Research Foundation Flanders, Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining the vaginal microbial community composition of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using Illumina MiSeq.	After metagenomic shotgun and amplicon sequencing with the Illumina MiSeq, bio-informatic tools will be used to analyze taxonomic and functional data. The researchers will specifically screen for Candida species (the main causative agent of vulvovaginal candidiasis) and other pathogenic taxa that can be associated with specific environmental conditions and lifestyle factors. Additionally, the researchers will also pay attention to health-promoting microorganisms (such as lactic acid bacteria and Saccharomyces species) that are present in the study cohort.	up to 4 years
Primary	Determining the vaginal metabolic profile of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using untargeted metabolomics analysis.	Swabs taken by the study cohort will be subjected to high throughput metabolomic analysis, including ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry. The researchers will specifically focus on the differences in the metabolic profile of women with vulvovaginal candidiasis and healthy women. Additionally, the researchers will also pay attention to correlating these metabolic profiles with specific environmental conditions and lifestyle factors.	up to 4 years
Primary	Determining the vaginal immunological profile of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using multiplex ELISA assays.	Swabs taken by the study cohort will be subjected to multiplex ELISA assays. More specifically, the researchers will measure the concentration of proinflammatory cytokines known to play a role during vulvovaginal candidiasis (IL-8, IL-1a, IL-1b, IL-6, IFNa, IFNb) and compare this with data from healthy women. Additionally, the researchers will also pay attention to correlating the concentrations of proinflammatory cytokines with specific environmental conditions and lifestyle factors.	up to 4 years
Primary	Characterizing the pathogenicity of Candida species isolated from women with vulvovaginal candidiasis using semi-high-throughput assays	Candida species isolated from the vagina of women with vulvovaginal candidiasis will be characterized for their pathogenicity. This will involve utilizing spectrophotometry, flow cytometry, and semi-automated image analysis to evaluate aspects such as growth, adhesion to epithelial cells (VK2/E6E7), and filamentation. Additionally, their capacity to cause damage will be assessed by measuring the percentage of lactate dehydrogenase released from epithelial cells through a cytotoxicity assay. Furthermore, the invasion potential of highly damaging strains will be quantified and analyzed in relation to the infection status of the women from whom the isolates were obtained.	up to 4 years