Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis

NCT ID: NCT06263465

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Vaginosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lactobacillus cispatus

10\^9 cfu,5 days

Group Type EXPERIMENTAL

Lactobacillus cispatus

Intervention Type OTHER

10\^9 cfu,5 days

Placebo

0 cfu,5 days

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

0 cfu,5 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactobacillus cispatus

10\^9 cfu,5 days

Intervention Type OTHER

placebo

0 cfu,5 days

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ZhuHai Hospital

OTHER

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hongwei Zhou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hongwei Zhou, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhuhai People'S Hospital

Zhuhai, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Muxuan Chen, Doctor

Role: CONTACT

+8613580561916

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jingya WU, Doctor

Role: primary

+8615902057821

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CALM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Probiotic Modulates Vaginal Microflora
NCT05302687 COMPLETED PHASE2/PHASE3