Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2022-05-12
2022-07-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Interventions
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No intervention, only sampling
No intervention
Eligibility Criteria
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Inclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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Gedea Biotech AB
INDUSTRY
Responsible Party
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Locations
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Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Research and Development Department, Berkshire Healthcare NHS Foundation Trust
Slough, , United Kingdom
Countries
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Other Identifiers
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CL4-2
Identifier Type: -
Identifier Source: org_study_id
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