VVC Sampling Study for Analysis Validation

Vulvovaginal Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05327192
• Other study ID #: CL4-2
• Status: Completed
• Start date: May 12, 2022
• Est. completion date: July 6, 2022

Study information

• Verified date: August 2022
• Source: Gedea Biotech AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 6, 2022
• Est. primary completion date: July 6, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vulvovaginal Candidiasis

Intervention

Other:
• No intervention, only sampling
No intervention

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Research and Development Department, Berkshire Healthcare NHS Foundation Trust	Slough

Sponsors (1)

Lead Sponsor	Collaborator
Gedea Biotech AB

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate resolution of bacterial DNA sequencing using 16S regions.		1 day
Primary	Correlation between vaginal sample DNA sequencing and VVC confirmed by clinical diagnosis and culture.		1 day