Vulvovaginal CandidiasisDeVEnIRNCT06397248
DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
An observational study of Vulvovaginal Candidiasis, run by University Hospital, Antwerp at 3 sites in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvovaginal Candidiasis
- How many people
- 300 participants
- Where
- 3 sitesBelgium
- Study dates
- 22 May 2024to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with an active Candida infection will be recruited during medical consultations. 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 the clinicians team.
Who may be able to join
- Female
- Age: 18 or older
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
University of Antwerp
Antwerp, Antwerpen, 2020
University of Antwerp
Antwerp, Antwerp, 2020
University Hospital Antwerp (UZA)
Edegem, Antwerpen, 2650
About this study
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
- Being tested
- No intervention
- Keywords
- Microbiome, Innate immunity, Mycology, Infectious diseases
- Medical subject headings
- Candidiasis, Vulvovaginal, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Healthy women | Healthy volunteers that do not have vaginal complaints or symptoms, and did not have any in the past 12 months. Receives: 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the vaginal microbial community composition of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using shotgun sequencing.
After metagenomic shotgun sequencing, bioinformatic 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.
Measured: up to 4 years
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.
Measured: up to 4 years
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.
Measured: up to 4 years
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.
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start22 May 2024
- Primary completion14 Dec 2025
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute, Universiteit Antwerpen, Research Foundation Flanders
- Responsible party
- Sponsor
- Investigators
- Sarah Lebeer, Prof., Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397248
- Sponsor's protocol ID
- EDGE 003471
- Other IDs
- S006424N, 5863
- Acronym
- DeVEnIR
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The metadata of participants in the study will be made available in a restricted access repository. * For samples and data sharing, the researchers will work with the legal department to establish Material/Data Transfer Agreements. * Sequencing data are available at the European Nucleotide Archive. * Physical samples are their origin will be stored at the decentral hub of the Antwerp biobank. * Concerning non-identifiable sample meta-data that the researchers will use in analysis and will later be published will be put available with access control via the European Genome-Phenome Archive (EGA), where data can be accessed as described upon agreeing to the harmonized Data Access Agreement (developed by the European Union standards for in silico models for personalized medicine EU-STANDS4PM, https://doi.org/10.6084/m9.figshare.23904300).
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
- ClinicalTrials.gov ID
- NCT06397248
- Acronym / sponsor ID
- DeVEnIR / EDGE 003471
- Conditions
- Vulvovaginal Candidiasis
- Keywords
- Microbiome, Innate immunity, Mycology, Infectious diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- KU Leuven, Leibniz Institute for Natural Product Research and Infection Biology Hans Knöll Institute, Universiteit Antwerpen, Research Foundation Flanders
- Study start
- 22 May 2024 (actual)
- Primary completion
- 14 Dec 2025 (actual)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy women | – | Other: No interventionHealthy volunteers that do not have vaginal complaints or symptoms, and did not have any in the past 12 months. |
| Women with an acute episode of vulvovaginal candidiasis | – | Other: No interventionWomen 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. |
| Women that suffer from recurrent episodes of vulvovaginal candidiasis | – | Other: No interventionThese women encounter such infections at least 3 times a year. These women are targeted both during an infection and in between infections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an active Candida infection will be recruited during medical consultations. 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 the clinicians team.
Key inclusion criteria (2 listed)
- Female
- Age: 18 or older
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Healthy women, Women that suffer from recurrent episodes of vulvovaginal candidiasis, Women with an acute episode of vulvovaginal candidiasis |
Primary outcome
Determining the vaginal microbial community composition of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using shotgun sequencing.
Time frame: up to 4 years
After metagenomic shotgun sequencing, bioinformatic 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.
Determining the vaginal metabolic profile of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using untargeted metabolomics analysis.
Time frame: up to 4 years
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.
Determining the vaginal immunological profile of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using multiplex ELISA assays.
Time frame: up to 4 years
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.
Characterizing the pathogenicity of Candida species isolated from women with vulvovaginal candidiasis using semi-high-throughput assays
Time frame: up to 4 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes. The metadata of participants in the study will be made available in a restricted access repository. * For samples and data sharing, the researchers will work with the legal department to establish Material/Data Transfer Agreements. * Sequencing data are available at the European Nucleotide Archive. * Physical samples are their origin will be stored at the decentral hub of the Antwerp biobank. * Concerning non-identifiable sample meta-data that the researchers will use in analysis and will later be published will be put available with access control via the European Genome-Phenome Archive (EGA), where data can be accessed as described upon agreeing to the harmonized Data Access Agreement (developed by the European Union standards for in silico models for personalized medicine EU-STANDS4PM, https://doi.org/10.6084/m9.figshare.23904300).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Lebeer, Prof. principal investigator
Universiteit Antwerpen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvovaginal Candidiasis, run by University Hospital, Antwerp at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the vaginal microbial community composition of both women who suffer from (recurrent) vulvovaginal candidiasis and healthy women using shotgun sequencing. (time frame: up to 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.