Patients With Bacterial VaginosisNCT06830122
Oral Lactobacillus Crispatus LCr86 Reduces Nugent Score and Improves Vaginal Microecology in Women With Intermediate Vaginal Microbiota
A study testing Probiotic in people with Patients With Bacterial Vaginosis, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
Lactobacillus crispatus LCr86 was selected as a test preparation to evaluate its effect on the Nugent score, vaginal pH, vaginal microbiota composition, serum inflammatory cytokines, and functional prediction analyse. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patients With Bacterial Vaginosis
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2025to 30 Mar 2026
- 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 19 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of childbearing age over 19 years of age and under 50 years of age.
- A person with a score of 4-6 on the Nugent core.
- A person who agrees to participate in the human application test before the human application test begins and has prepared the written consent form.
- A person who agrees to follow the contraception methods permitted by PI.
Who cannot join
- Those who are currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal tract/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease, tumor and malignant.
- The subjects who treated for vaginal or urinary tract infection as of within 3 months (e.g., candidiasis, trichomonas infection, gonorrhea, chlamydial infection, etc.).
- The subjects with vaginal or urinary tract bleeding, or abnormality.
- The subjects who has been given antibiotics, antimicrobial agents, steroids, immunosuppressants, estrogen-based drugs (pneumonia-related drugs are allowed) within 4 weeks of visit 1 (but those who used them within 2 weeks of visit 1 cannot participate in the test).
- The subjects who has consumed health functional foods related to improving immune function and vaginal health.
- The subjects who has administered probiotics and prebiotics within two weeks based on visit 1 or has continuously administered or ingested fermented milk and lactobacillus products.
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- Allergic constitution or hypersensitivity to known components of the study drug.
- The subjects who has received salivary treatment for sedimentation, women's cleansers, vaginal sanitizers, left fumigation, and vaginal health within two week of screening visit.
- The subjects with unregulated hypertension (above 160mmHg or 90mmHg of blood pressure).
- The subjects who AST (GOT) or ALT (GPT) is at least three times the normal limit of the testing agency.
- The subjects who are sensitive or allergic to the ingredients of this human-applied test food.
- Subjects who are pregnant, breastfeeding, or planning to conceive within three months.
- If the daily alcohol intake is more than 20g.
- Excessive smokers (≥20 pieces/day).
- The subjects who has participated in another interventional clinical trial within three month of the commencement of this trial or who has a plan to participate in another interventional clinical trial (including a human application test) after the commencement of this human application test.
- The subjects who is deemed inappropriate by the human application test testers for this human application test.
- Other vaginitis: Trichomonas vaginalis (TV) infection or fungal infection.
Trial locations and contacts
1 site in 1 country.
About this study
Lactobacillus crispatus LCr86 was selected as a test preparation to evaluate its effect on the Nugent score, vaginal pH, vaginal microbiota composition, serum inflammatory cytokines, and functional prediction analyse.
- Conditions
- Patients With Bacterial Vaginosis
- Being tested
- Probiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The experimental phase of this study will last 8 weeks and each subject will receive 4 follow-up visits (week 0, week 2, week 4, week 8).
PlaceboDietary supplement
The experimental phase of this study will last 8 weeks and each subject will receive 4 follow-up visits (week 0, week 2, week 4, week 8).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | 10B CFU/strip/day LCr86; Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | maltodextrin, one strip/day; Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nugent score
Vaginal swab specimens were Gram-stained and independently scored by two trained professionals according to the standard method. Nugent scores range from 0 to 10, with scores of 0-3 considered normal, 4-6 indicating an intermediate state, and 7-10 suggesting bacterial vaginosis.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start15 Jul 2025
- Primary completion10 Jan 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830122
- Sponsor's protocol ID
- WK2025005
- Status last verified
- May 2026
- First submitted
- 11 Feb 2025
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Lactobacillus Crispatus LCr86 Reduces Nugent Score and Improves Vaginal Microecology in Women With Intermediate Vaginal Microbiota
- ClinicalTrials.gov ID
- NCT06830122
- Acronym / sponsor ID
- WK2025005
- Conditions
- Patients With Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 17 Feb 2025 (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.
Lactobacillus crispatus LCr86 was selected as a test preparation to evaluate its effect on the Nugent score, vaginal pH, vaginal microbiota composition, serum inflammatory cytokines, and functional prediction analyse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic10B CFU/strip/day LCr86; |
| Placebo group | Placebo comparator | Dietary Supplement: Placebomaltodextrin, one strip/day; |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women of childbearing age over 19 years of age and under 50 years of age.
- A person with a score of 4-6 on the Nugent core.
- A person who agrees to participate in the human application test before the human application test begins and has prepared the written consent form.
- A person who agrees to follow the contraception methods permitted by PI.
Key exclusion criteria (17 listed)
- Those who are currently being treated for severe cardiovascular system, immune system, respiratory system, gastrointestinal tract/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease, tumor and malignant.
- The subjects who treated for vaginal or urinary tract infection as of within 3 months (e.g., candidiasis, trichomonas infection, gonorrhea, chlamydial infection, etc.).
- The subjects with vaginal or urinary tract bleeding, or abnormality.
- The subjects who has been given antibiotics, antimicrobial agents, steroids, immunosuppressants, estrogen-based drugs (pneumonia-related drugs are allowed) within 4 weeks of visit 1 (but those who used them within 2 weeks of visit 1 cannot participate in the test).
- The subjects who has consumed health functional foods related to improving immune function and vaginal health.
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 |
|---|---|---|
| ProbioticThe experimental phase of this study will last 8 weeks and each subject will receive 4 follow-up visits (week 0, week 2, week 4, week 8). | Dietary supplement | Probiotic group |
| PlaceboThe experimental phase of this study will last 8 weeks and each subject will receive 4 follow-up visits (week 0, week 2, week 4, week 8). | Dietary supplement | Placebo group |
Primary outcome
Change in Nugent score
Time frame: 8 weeks
Vaginal swab specimens were Gram-stained and independently scored by two trained professionals according to the standard method. Nugent scores range from 0 to 10, with scores of 0-3 considered normal, 4-6 indicating an intermediate state, and 7-10 suggesting bacterial vaginosis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Patients With Bacterial Vaginosis, run by Wecare Probiotics Co., Ltd. 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 26 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nugent score (time frame: 8 weeks). 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 26 May 2026.