Bacterial VaginosisPhase 4NCT04771728
A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis
A Phase 4 study testing Metronidazole vaginal suppositories and Metronidazole vaginal suppositories and Probiotics(Umeta-mimi) in people with Bacterial Vaginosis, run by Peking University Shenzhen Hospital at 1 site in China.
Trial summary
The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Metronidazole vaginal suppositories and Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 55 years old, with history of sexual activity,
- Amsel criterion for diagnosing BV
- Sign informed consent
Who cannot join
- History of systemic organic diseases or psychiatric diseases
- Planning for or during pregnancy, lactation, menstruation
- within 5 days of onset of the disease, any antibiotics has been used
- Long-term use of contraceptives or immunosuppressant
- Anaphylactic constitution or allergic to known ingredients of research drugs
- No same fixed partner (RSP) before and after treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hosptal
Shenzhen, Guangdong, 518036
Yiheng Liang, M.D., 8675583923333 ext. 5505, 13510331823@163.com
About this study
Official title: Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis
Read the detailed description
Studies have shown that oral Probiotics(Umeta-mimi) can significantly promote the recovery of vaginal flora mainly because intestinal microbiota can migrate and affect vaginal microecology. This project aims to evaluate the efficacy of oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis (BV) and to explore the correlation between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and intestinal feces at the time of baseline phase,14 days after treatment， the first month after treatment, 5-7 days after third menstruation after treatment and 5-7 days after sixth menstruation after treatment
- Conditions
- Bacterial Vaginosis
- Being tested
- Metronidazole vaginal suppositories, Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole vaginal suppositoriesDrug
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )
Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)Drug
Also called Metronidazole vaginal suppositories adn Probiotics(Umeta-mimi）
Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days）
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole vaginal | Active comparator | Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) Receives: Drug: Metronidazole vaginal suppositories |
| Metronidazole vagianl and Probiotics(Umeta-mimi) | Experimental | Metronidazole:Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) Probiotics:Oral Umeta-mimi( 5×109cfu per day,30 days） Receives: Drug: Metronidazole vaginal suppositories and Probiotics(Umeta-mimi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate of BV
Assessments with different Units of Measure:clinical symptoms such as itching or burning; "fishy" smell; homogeneous thin vaginal discharge;Nugent score; pH>4.5; clue cell.
Measured: 14 days after treatment
Secondary outcomes (3)
Recurrence of BV
Nugent score
Measured: The first month after treatment
Recurrence of BV
Nugent score
Measured: 5-7 days after third menstruation after treatment
Recurrence of BV
Nugent score
Measured: 5-7 days after sixth menstruation after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Feb 2020
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BGI, China
- Responsible party
- Principal investigator, Shangrong Fan, Peking University Shenzhen Hospital
- Investigators
- Ruifang Wu, M.D., Study director, Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771728
- Sponsor's protocol ID
- PUshenzhenH2020-0310
- Status last verified
- Jun 2025
- First submitted
- 28 Sep 2020
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qi F, Fan S, Fang C, Ge L, Lyu J, Huang Z, Zhao S, Zou Y, Huang L, Liu X, Liang Y, Zhang Y, Zhong Y, Zhang H, Xiao L, Zhang X. Orally administrated Lactobacillus gasseri TM13 and Lactobacillus crispatus LG55 can restore the vaginal health of patients recovering from bacterial vaginosis. Front Immunol. 2023 Jul 27;14:1125239. doi: 10.3389/fimmu.2023.1125239. eCollection 2023.
PubMed 37575226
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital
- ClinicalTrials.gov ID
- NCT04771728
- Acronym / sponsor ID
- PUshenzhenH2020-0310
- Conditions
- Bacterial Vaginosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Peking University Shenzhen HospitalUniversity, hospital or other
- Collaborators
- BGI, China
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 25 Feb 2021 (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 investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis
Detailed description
Studies have shown that oral Probiotics(Umeta-mimi) can significantly promote the recovery of vaginal flora mainly because intestinal microbiota can migrate and affect vaginal microecology. This project aims to evaluate the efficacy of oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories(7 days) in the treatment of bacterial vaginosis (BV) and to explore the correlation between vaginal flora and fecal flora by detecting the metagenomics of vaginal secretions and intestinal feces at the time of baseline phase,14 days after treatment， the first month after treatment, 5-7 days after third menstruation after treatment and 5-7 days after sixth menstruation after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronidazole vaginal | Active comparator | Drug: Metronidazole vaginal suppositoriesMetronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) |
| Metronidazole vagianl and Probiotics(Umeta-mimi) | Experimental | Drug: Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)Metronidazole:Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) Probiotics:Oral Umeta-mimi( 5×109cfu per day,30 days） |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18 to 55 years old, with history of sexual activity,
- Amsel criterion for diagnosing BV
- Sign informed consent
Key exclusion criteria (6 listed)
- History of systemic organic diseases or psychiatric diseases
- Planning for or during pregnancy, lactation, menstruation
- within 5 days of onset of the disease, any antibiotics has been used
- Long-term use of contraceptives or immunosuppressant
- Anaphylactic constitution or allergic to known ingredients of research drugs
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 |
|---|---|---|
| Metronidazole vaginal suppositoriesMetronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) | Drug | Metronidazole vaginal |
| Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)Also: Metronidazole vaginal suppositories adn Probiotics(Umeta-mimi）Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days） | Drug | Metronidazole vagianl and Probiotics(Umeta-mimi) |
Primary outcome
Cure rate of BV
Time frame: 14 days after treatment
Assessments with different Units of Measure:clinical symptoms such as itching or burning; "fishy" smell; homogeneous thin vaginal discharge;Nugent score; pH>4.5; clue cell.
3 secondary outcomes
Recurrence of BV
Time frame: The first month after treatment
Recurrence of BV
Time frame: 5-7 days after third menstruation after treatment
Recurrence of BV
Time frame: 5-7 days after sixth menstruation after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 37575226Qi F, Fan S, Fang C, Ge L, Lyu J, Huang Z, Zhao S, Zou Y, Huang L, Liu X, Liang Y, Zhang Y, Zhong Y, Zhang H, Xiao L, Zhang X. Orally administrated Lactobacillus gasseri TM13 and Lactobacillus crispatus LG55 can restore the vaginal health of patients recovering from bacterial vaginosis. Front Immunol. 2023 Jul 27;14:1125239. doi: 10.3389/fimmu.2023.1125239. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
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Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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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.
Ruifang Wu, M.D. study director
Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metronidazole vaginal suppositories and Metronidazole vaginal suppositories and Probiotics(Umeta-mimi) in people with Bacterial Vaginosis, run by Peking University Shenzhen 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shangrong Fan, M.D. (86-755-83923333 ext. 5505, fanshangrong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate of BV (time frame: 14 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771728, which also lists 1 linked publication.
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 12 Jun 2025.