Clinical trial NCT06397248: DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
Official title: DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vulvovaginal Candidiasis
Keywords: Microbiome
Innate immunity
Mycology
Infectious diseases
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute
name: Universiteit Antwerpen
name: Research Foundation Flanders
First posted: 2024-05-02
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an active Candida infection will be recruited during consultations with the responsible physicians: Prof. Gilbert Donders and Prof. Veronique Verhoeven. This subgroup will include both acute vulvovaginal candidiasis patients (episodic VVC; n=100) and recurrent VVC patients (episodic RVVC; n=100). The active Candida infection of these patients will be confirmed through clinical evaluation. Furthermore, the responsible physicians will also recruit patients who have had at least three Candida infections in the past 12 months or have already been diagnosed with RVVC. This subgroup (non-episodic RVVC; n=100) does not have an active Candida infection at the time of sample collection. Additionally, a subgroup of healthy volunteers (n=200) will be recruited through various channels. These channels will also be used to reach VVC and RVVC patients and then refer them to Prof. Donders' team.

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.


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)

Primary outcomes:
measure: Determining the vaginal microbial community composition of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using Illumina MiSeq.
timeFrame: up to 4 years
measure: Determining the vaginal metabolic profile of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using untargeted metabolomics analysis.
timeFrame: up to 4 years
measure: Determining the vaginal immunological profile of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using multiplex ELISA assays.
timeFrame: up to 4 years
measure: Characterizing the pathogenicity of Candida species isolated from women with vulvovaginal candidiasis using semi-high-throughput assays
timeFrame: up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tienen
country: Belgium
facility: Femicare vzw
state: Vlaams-Brabant
city: Antwerpen
country: Belgium
facility: University of Antwerp
city: Antwerp
country: Belgium
facility: University of Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Sarah Lebeer, Prof.
role: PRINCIPAL_INVESTIGATOR
References: