NCT05327192

VVC Sampling Study for Analysis Validation

Collection of Samples From Women Diagnosed With Vulvovaginal Candidiasis for Validation of Vaginal Microbiome Analysis Method

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Gedea Biotech AB · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulvovaginal Candidiasis

Interventions

Type	Name	Description
OTHER	No intervention, only sampling	No intervention

Timeline

• Start date: 2022-05-12
• Primary completion: 2022-07-06
• Completion: 2022-07-06
• First posted: 2022-04-14
• Last updated: 2022-08-18

Locations

2 sites across 1 country: United Kingdom