Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining

Not yet recruiting

• Conditions: Vaginal Infection

• Registration Number: NCT05997160
• Lead Sponsor: Tianjin Medical University General Hospital

Brief 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.

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 Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-10
• Study First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Study First Posted: 2023-08-18
• Last Update Posted: 2023-08-18
• Study Start: 2023-09-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 5590

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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