Understanding vulvovaginal candidiasis and its treatment
DeVEnIR: Defining Vulvovaginal Candidiasis - Elements of Infection and Remedy
This study looks at the causes and characteristics of recurring vaginal yeast infections in women aged 18-50 to help improve how they are diagnosed and treated.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 3 sites (Tienen, Vlaams-Brabant and 2 other locations) |
| Trial ID | NCT06397248 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on vulvovaginal candidiasis (VVC), a common fungal infection affecting women. It aims to address the knowledge gap in female-specific health by exploring the microbiome, immune responses, and pathogen characteristics associated with recurrent VVC. The study will involve female participants aged 18-50 who are premenopausal, and it will collect data without any interventions. By characterizing these elements, the research seeks to improve diagnosis and treatment strategies for VVC.
Who should consider this trial
Good fit: Ideal candidates for this study are premenopausal women aged 18-50 who do not have recent vaginal complaints or have not used antibiotics or antifungals in the past month.
Not a fit: Patients who are pregnant or have self-reported vaginal complaints in the past year will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic and treatment options for women suffering from vulvovaginal candidiasis.
How similar studies have performed: Other studies have shown success in exploring the microbiome's role in infections, but this specific focus on vulvovaginal candidiasis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Tienen, Vlaams-Brabant and 2 other locations
- Femicare vzw — Tienen, Vlaams-Brabant, Belgium (Recruiting)
- University of Antwerp — Antwerpen, Belgium (Recruiting)
- University of Antwerp — Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Sarah Lebeer, Prof. — Universiteit Antwerpen
- Study coordinator: Gilbert Donders, Professor
- Email: gilbert.donders@femicare.net
- Phone: +3216 80 81 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.