Bacterial VaginosisNCT06263465
Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis
A study testing Lactobacillus cispatus in people with Bacterial Vaginosis, run by Zhujiang Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Lactobacillus cispatus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. History of sexual behaviour 2.18-55 years old 3. Women were diagnosed as bacterial vaginosis
Who cannot join
- During pregnancy, or within 8 weeks after delivery;
- presence of systemic diseases (such as SLE, malignant tumors, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhuhai People'S Hospital
Zhuhai, Guangdong, 519050
Jingya WU, Doctor, +8615902057821
About this study
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.
Read the 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.
- Conditions
- Bacterial Vaginosis
- Being tested
- Lactobacillus cispatus, placebo
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus cispatusOther
10^9 cfu,5 days
placeboOther
0 cfu,5 days
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus cispatus | Experimental | 10^9 cfu,5 days Receives: Other: Lactobacillus cispatus |
| Placebo | Placebo comparator | 0 cfu,5 days Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BV recurrence rate
Primary Outcome Measure
Measured: month 12
Secondary outcomes (2)
vaginal secretions 16s rRNA gene sequencing
Secondary Outcome Measures
Measured: 2 weeks，month 1，month 3、month 6、month 12
BV recurrence rate
Secondary Outcome Measures
Measured: 2 weeks，month 1，month 3、month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start18 Mar 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ZhuHai Hospital
- Responsible party
- Principal investigator, Hongwei Zhou, Zhujiang Hospital
- Investigators
- Hongwei Zhou, Professor, Principal investigator, Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263465
- Sponsor's protocol ID
- CALM
- Status last verified
- May 2024
- First submitted
- 23 Jan 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT06263465
- Acronym / sponsor ID
- CALM
- Conditions
- Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- ZhuHai Hospital
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus cispatus | Experimental | Other: Lactobacillus cispatus10^9 cfu,5 days |
| Placebo | Placebo comparator | Other: placebo0 cfu,5 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. History of sexual behaviour 2.18-55 years old 3. Women were diagnosed as bacterial vaginosis
Key exclusion criteria (2 listed)
- During pregnancy, or within 8 weeks after delivery;
- presence of systemic diseases (such as SLE, malignant tumors, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus cispatus10^9 cfu,5 days | Other | Lactobacillus cispatus |
| placebo0 cfu,5 days | Other | Placebo |
Primary outcome
BV recurrence rate
Time frame: month 12
Primary Outcome Measure
2 secondary outcomes
vaginal secretions 16s rRNA gene sequencing
Time frame: 2 weeks，month 1，month 3、month 6、month 12
BV recurrence rate
Time frame: 2 weeks，month 1，month 3、month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongwei Zhou, Professor principal investigator
Department of Laboratory Medicine, Zhujiang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus cispatus in people with Bacterial Vaginosis, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muxuan Chen, Doctor (+8613580561916, muxuanchen@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BV recurrence rate (time frame: month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.