Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis

Zhujiang Hospital

Status: Enrolling

Conditions: Bacterial Vaginosis

Treatments: Other: Lactobacillus cispatus; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06263465

CALM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Lactobacillus cispatus

Experimental group

Description:

10\^9 cfu,5 days

Treatment:

Other: Lactobacillus cispatus

Placebo

Placebo Comparator group

Description:

0 cfu,5 days

Treatment:

Other: placebo