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VVC Sampling Study for Analysis Validation

Sponsor
Gedea Biotech AB (Industry)
Overall Status
Completed
CT.gov ID
NCT05327192
Collaborator
(none)
10
Enrollment
2
Locations
1.8
Actual Duration (Months)
5
Patients Per Site
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention, only sampling

Study Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Collection of Samples From Women Diagnosed With Vulvovaginal Candidiasis for Validation of Vaginal Microbiome Analysis Method
Actual Study Start Date :
May 12, 2022
Actual Primary Completion Date :
Jul 6, 2022
Actual Study Completion Date :
Jul 6, 2022

Outcome Measures

Primary Outcome Measures

  1. Correlation between vaginal sample DNA sequencing and VVC confirmed by clinical diagnosis and culture. [1 day]

Other Outcome Measures

  1. Evaluate resolution of bacterial DNA sequencing using 16S regions. [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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:

  3. 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.

  4. Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.

  5. Having decisional capacity and providing written informed consent

  6. Signed informed consent and willing and able to comply with all study requirements

Exclusion Criteria:

None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nottingham University Hospitals NHS Trust Nottingham United Kingdom NG5 1PB
2 Research and Development Department, Berkshire Healthcare NHS Foundation Trust Slough United Kingdom

Sponsors and Collaborators

  • Gedea Biotech AB

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gedea Biotech AB
ClinicalTrials.gov Identifier:
NCT05327192
Other Study ID Numbers:
  • CL4-2
First Posted:
Apr 14, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal

Study Results

No Results Posted as of Aug 18, 2022