Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis

Bacterial Vaginosis Clinical Trial

Official title:

Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263465
• Other study ID #: CALM
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Zhujiang Hospital
• Contact: Muxuan Chen, Doctor
• Phone: +8613580561916
• Email: muxuanchen[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Other:
• Lactobacillus cispatus
10^9 cfu,5 days
• placebo
0 cfu,5 days

Locations

Country	Name	City	State
China	Zhuhai People'S Hospital	Zhuhai	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhujiang Hospital	ZhuHai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BV recurrence rate	Primary Outcome Measure	month 12
Secondary	vaginal secretions 16s rRNA gene sequencing	Secondary Outcome Measures	2 weeks,month 1,month 3?month 6?month 12
Secondary	BV recurrence rate	Secondary Outcome Measures	2 weeks,month 1,month 3?month 6