NCT06263465

Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
OTHER	Lactobacillus cispatus	10\^9 cfu,5 days
OTHER	placebo	0 cfu,5 days

Timeline

• Start date: 2024-03-18
• Primary completion: 2025-07-01
• Completion: 2025-12-31
• First posted: 2024-02-16
• Last updated: 2024-05-14

Locations

1 site across 1 country: China