Patients With Bacterial VaginosisNCT06821789
Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women
A study testing Probiotic in people with Patients With Bacterial Vaginosis, run by Wecare Probiotics Co., Ltd..
Trial summary
In this study, Lacticaseibacillus rhamnosus LRa05 was selected as test preparations to observe the clinical efficacy in the intervention trial of combined antibiotic therapy, and to evaluate its effects on the cure rate, recurrence rate and vaginal microbiota of patients with bacterial vaginitis. Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 30 May 2026
- Phase
- Interventional
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years old, sexual activity, premenopausal women;
- Nugent score for diagnosing BV ≥7;
- Signed informed consent.
Who cannot join
- Mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
- history of systemic organic disease or psychiatric illness;
- Planning pregnancy, breastfeeding, menstruation;
- within 5 days of the onset of the disease, any antibiotics have been used;
- long-term use of contraceptives or immunosuppressants;
- Allergic constitution or hypersensitivity to known components of the study drug.
About this study
Official title: Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women: a Randomized, Double-blind, Placebo-controlled Trial
In this study, Lacticaseibacillus rhamnosus LRa05 was selected as test preparations to observe the clinical efficacy in the intervention trial of combined antibiotic therapy, and to evaluate its effects on the cure rate, recurrence rate and vaginal microbiota of patients with bacterial vaginitis.
- 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 4, week 8, week 20).
PlaceboDietary supplement
The experimental phase of this study will last 8 weeks and each subject will receive 4 follow-up visits (week 0, week 4, week 8, week 20).
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | Conventional medication (ornidazole vaginal suppositories for 7 days) + 30B CFU/strip/day LRa05 (before meals); Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Conventional medication (ornidazole vaginal suppositories for 7 days) + maltodextrin, one strip/day (before meals); Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate of bacterial vaginosis
The Nugent score of ≤3 is considered successful in bacterial vaginosis treatment
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 posted12 Feb 2025
- Study start15 Mar 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 May 2026 (estimated)
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
- 60 participants (estimated)
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
- NCT06821789
- Sponsor's protocol ID
- WK2025004
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 19 Feb 2025
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women: a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06821789
- Acronym / sponsor ID
- WK2025004
- Conditions
- Patients With Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 12 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.
In this study, Lacticaseibacillus rhamnosus LRa05 was selected as test preparations to observe the clinical efficacy in the intervention trial of combined antibiotic therapy, and to evaluate its effects on the cure rate, recurrence rate and vaginal microbiota of patients with bacterial vaginitis.
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: ProbioticConventional medication (ornidazole vaginal suppositories for 7 days) + 30B CFU/strip/day LRa05 (before meals); |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboConventional medication (ornidazole vaginal suppositories for 7 days) + maltodextrin, one strip/day (before meals); |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years old, sexual activity, premenopausal women;
- Nugent score for diagnosing BV ≥7;
- Signed informed consent.
Key exclusion criteria (6 listed)
- Mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
- history of systemic organic disease or psychiatric illness;
- Planning pregnancy, breastfeeding, menstruation;
- within 5 days of the onset of the disease, any antibiotics have been used;
- long-term use of contraceptives or immunosuppressants;
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 4, week 8, week 20). | 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 4, week 8, week 20). | Dietary supplement | Placebo group |
Primary outcome
Cure rate of bacterial vaginosis
Time frame: 8 weeks
The Nugent score of ≤3 is considered successful in bacterial vaginosis 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 19 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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..
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: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
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?
Cure rate of bacterial vaginosis (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 19 Feb 2025.