Vulvovaginal Candidiasis
Conditions
Brief summary
This is a biomarker multi-centre study to validate an extraction method of fungal and bacterial DNA extracted from vaginal swabs from adult women with confirmed VVC. The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms. Vaginal samples will be examined under a microscope for yeast forms (hyphae or pseudohyphae) or budding yeast. If the Investigator assesses that the patient has VVC, based on examination and the potassium hydroxide (KOH) test, two vaginal secretion samples will be collected by a vaginal swab. One sample will be cultured to verify the presence of Candida and the other will be used for sequencing analysis of the vaginal microbiome. Samples from a total of 10 women are planned to be taken.
Interventions
OTHERNo intervention, only sampling
No intervention
Sponsors
Gedea Biotech AB
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult women aged 18 years or older 2. Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings: 1. At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation. 2. Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts. 3. Having decisional capacity and providing written informed consent 4. Signed informed consent and willing and able to comply with all study requirements
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between vaginal sample DNA sequencing and VVC confirmed by clinical diagnosis and culture. | 1 day |
Other
| Measure | Time frame |
|---|---|
| Evaluate resolution of bacterial DNA sequencing using 16S regions. | 1 day |
Countries
United Kingdom
Outcome results
None listed