Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining (VENUS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaginal Infection

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 5590

Contacts and Locations

• Study Contact: Name: Fengxia Xue, PhD; Phone Number: 8615022655806; Email: qiwenhui1987@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

VENUS study plans to enrol 5590 participants, aged 15-49 years, from visiting our research settings across the country who evaluate vaginal discharge based on Gram-stained smear.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
hospital name + infection type + number; There is no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The score for smear	This score consists of uniformity, impurities, cell degeneration, and clarity for evaluating a smear.	December 2023
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
Relative Abundance	Relative Abundance is from 16S rRNA gene sequencing and metagenomic sequencing for patients without clearly diagnosis.	May 2024
Intensity	The intensity is tested by liquid chromatography-tandem mass spectrometry for targeted metabolites for patients without clearly diagnosis.	May 2024

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital
• Collaborators: Jiangsu Bioperfectus Technologies Co., Ltd
• Investigators: Principal Investigator: Fengxia Xue, PhD, Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB2023-YX-022-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No