Vaginal Infection Clinical Trial
— VENUSOfficial title:
Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining
The goal of this observational study is to explore a standardized sample process for improving the accuracy of vaginal microbiota evaluation and to explore a more complete and comprehensive method for vaginal microbiota evaluation based on gram staining.
Status | Not yet recruiting |
Enrollment | 5590 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 49 Years |
Eligibility | Inclusion Criteria: - Non-pregnant women who visit our research settings and conduct vaginal discharge examination based on Gram-stained smear. - No sexual intercourse, vaginal douching, or vaginal medication within the last 72 hours. - Not during menstruation (menstrual period ended =3 days ago). exclusion Criteria: - Receiving systemic or vaginal antifungal or antibiotic treatment within the past week. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University General Hospital | Jiangsu Bioperfectus Technologies Co., Ltd |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The score for smear | This score consists of uniformity, impurities, cell degeneration, and clarity for evaluating a smear. | December 2023 | |
Primary | Diagnosis of vaginitis type | The Diagnosis of vaginitis type based on Gram-stained smear and antigen testing, including aerobic vaginitis(AV), bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), and normal. | March 2024 | |
Primary | Relative Abundance | Relative Abundance is from 16S rRNA gene sequencing and metagenomic sequencing for patients without clearly diagnosis. | May 2024 | |
Primary | Intensity | The intensity is tested by liquid chromatography-tandem mass spectrometry for targeted metabolites for patients without clearly diagnosis. | May 2024 |
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