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NCT06263465 Clinical Trial

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
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.)

Study Design

Related Conditions & MeSH terms

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
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Active, not recruiting NCT00536848 - The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients Phase 2/Phase 3
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