Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining

Vaginal Infection Clinical Trial

— VENUS  

Official title:

Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05997160
• Other study ID #: IRB2023-YX-022-01
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Tianjin Medical University General Hospital
• Contact: Fengxia Xue, PhD
• Phone: 8615022655806
• Email: qiwenhui1987[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This study consists of two sub-studies:

1. Sub-study on Standardized method of Microscopic Slide Preparation: this sub-study aims to compare different slide preparation methods and dilution levels based on various aspects, including uniformity, impurities, clarity and so on, and then explore the optimal method and dilution level. Additionally, it will summarize the conversion method for white blood cells between wet mount and gram staining, and for white blood cells between high-power microscopy and oil immersion microscopy.

2. Sub-study on Vaginal Microbiota Evaluation on Gram Staining: For patients with diagnosed vaginal infection type, it will calculate the consistency of results between different laboratories. And it will evaluate the effectiveness combined artificial intelligence technology and other technological platforms. Besides, for patients without diagnosed vaginal infection type, different methods such as 16S rRNA gene sequencing and metagenomic sequencing are used for analysis and profiling to guide treatment.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Vaginal Infection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital	Jiangsu Bioperfectus Technologies Co., Ltd

Outcome

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