Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis

Not Applicable

Recruiting

• Conditions: Bacterial Vaginosis
• Interventions: Other: Lactobacillus cispatus; Other: placebo

• Registration Number: NCT06263465
• Lead Sponsor: Zhujiang Hospital

Brief Summary

The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis.

Detailed Description

The volunteers will be recruited from the women who come to the hospital to do the bacterial vaginosis test. After being informed about the potential risks, each volunteer giving written informed consent will be asked to complete a questionnaire.

Then, posterior fornix of vagina secretions will be taken from each volunteer to perform 16S rRNA gene sequencing microecology assessment , Clue cell detection and amine test.

After 2weeks ,1 month ,3 months,6 months,12 monthssince the entry, each volunteer will be asked to go back to research center to do the same sampling and examination as previously did in entry.

Study Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-16
• Study Start: 2024-03-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1. History of sexual behaviour 2.18-55 years old 3. Women were diagnosed as bacterial vaginosis

Exclusion Criteria

1. During pregnancy, or within 8 weeks after delivery;
2. presence of systemic diseases (such as SLE, malignant tumors, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus cispatus	Lactobacillus cispatus	10\^9 cfu,5 days
Placebo	placebo	0 cfu,5 days

Primary Outcome Measures

Name	Time	Method
BV recurrence rate	month 12	Primary Outcome Measure

Secondary Outcome Measures

Name	Time	Method
BV recurrence rate	2 weeks，month 1，month 3、month 6	Secondary Outcome Measures
vaginal secretions 16s rRNA gene sequencing	2 weeks，month 1，month 3、month 6、month 12	Secondary Outcome Measures

Trial Locations

Locations (1)

Zhuhai People'S Hospital; 🇨🇳 Zhuhai, Guangdong, China