Vaginal microbiome transplantation for treating bacterial vaginosis in women
Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis
This study is testing if a new treatment using healthy bacteria from other women can help women with bacterial vaginosis feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Zhuhai, Guangdong) |
| Trial ID | NCT06263465 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of a new technique for vaginal microbiome transplantation using Lactobacillus cispatus sourced from healthy donors to treat bacterial vaginosis. Women diagnosed with bacterial vaginosis will be recruited and undergo a series of assessments, including vaginal secretions sampling and microbiome analysis, at multiple time points over a year. Participants will provide informed consent and complete questionnaires to monitor their health and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-55 who have been diagnosed with bacterial vaginosis.
Not a fit: Patients who are pregnant, have recently given birth, or have systemic diseases such as lupus or cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for women suffering from bacterial vaginosis.
How similar studies have performed: While the approach of microbiome transplantation is gaining interest, this specific technique using Lactobacillus cispatus is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Zhuhai, Guangdong
- Zhuhai People'S Hospital — Zhuhai, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Hongwei Zhou, Professor — Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
- Study coordinator: Muxuan Chen, Doctor
- Email: muxuanchen@126.com
- Phone: +8613580561916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.