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VVC Sampling Study for Analysis Validation

NCT05327192 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2022-08-18

No results posted yet for this study

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

OTHER

No intervention, only sampling

No intervention

Sponsors & Collaborators

  • Gedea Biotech AB

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2022-07-06
Completion
2022-07-06

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05327192 on ClinicalTrials.gov