Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention, only sampling | Other | No intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between vaginal sample DNA sequencing and VVC confirmed by clinical diagnosis and culture. | 1 day |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate resolution of bacterial DNA sequencing using 16S regions. | 1 day |
Inclusion Criteria:
Adult women aged 18 years or older
Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:
Having decisional capacity and providing written informed consent
Signed informed consent and willing and able to comply with all study requirements
Exclusion Criteria:
None
Not provided
Not provided
Not provided
The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals NHS Trust | Nottingham | NG5 1PB | United Kingdom | |||
| Research and Development Department, Berkshire Healthcare NHS Foundation Trust |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Vaginal samples to study bacterial DNA
| Slough |
| United Kingdom |
| D014848 |
| Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |