Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis

May 13, 2024 updated by: Hongwei Zhou, Zhujiang Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China, 519050
        • Recruiting
        • Zhuhai People's Hospital
        • Contact:
          • Jingya WU, Doctor
          • Phone Number: +8615902057821

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lactobacillus cispatus
10^9 cfu,5 days
Other: Lactobacillus cispatus
10^9 cfu,5 days
Placebo Comparator: Placebo
0 cfu,5 days
Other: placebo
0 cfu,5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BV recurrence rate
Time Frame: month 12
Primary Outcome Measure
month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vaginal secretions 16s rRNA gene sequencing
Time Frame: 2 weeks，month 1，month 3、month 6、month 12
Secondary Outcome Measures
2 weeks，month 1，month 3、month 6、month 12
BV recurrence rate
Time Frame: 2 weeks，month 1，month 3、month 6
Secondary Outcome Measures
2 weeks，month 1，month 3、month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Collaborators

ZhuHai Hospital

Investigators

  • Principal Investigator: Hongwei Zhou, Professor, Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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