Vulvovaginal CandidiasisNCT07727967
Oral Lactobacillus Crispatus Lc-G22 as Adjunctive Therapy for Vulvovaginal Candidiasis
A study testing Lactobacillus crispatus Lc-G22 in people with Vulvovaginal Candidiasis, run by BioGrowing Co., Ltd at 1 site in China.
Trial summary
This single-center, randomized, single-blind, placebo-controlled trial aimed to evaluate the efficacy and safety of oral Lactobacillus crispatus Lc-G22 as adjunctive therapy to clotrimazole for preventing recurrence of vulvovaginal candidiasis (VVC). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- What is being tested?
- Lactobacillus crispatus Lc-G22
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Oct 2024
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years
- Female
- History of two or more clinically and mycologically confirmed vulvovaginal candidiasis episodes within the preceding 12 months
- Current episode with positive vaginal fungal microscopy (10% KOH wet mount)
- Presence of typical clinical symptoms (e.g., vulvar pruritus, abnormal vaginal discharge) and signs
- Willing to provide written informed consent
Who cannot join
- Severe psychiatric disorders
- Long-term (>4 weeks) use of systemic antibiotics, immunosuppressants, or corticosteroids
- Known allergy to clotrimazole or any component of the study product
- Diabetes mellitus
- Pregnancy or lactation
- Use of other probiotic supplements within 4 weeks prior to enrollment
- Other conditions deemed unsuitable for participation by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong
About this study
Official title: Efficacy and Safety of Oral Lactobacillus Crispatus Lc-G22 as Adjunctive Therapy to Clotrimazole for Preventing Recurrence of Vulvovaginal Candidiasis: A Single-Center, Randomized, Single-Blind, Placebo-Controlled Trial
This single-center, randomized, single-blind, placebo-controlled trial aimed to evaluate the efficacy and safety of oral Lactobacillus crispatus Lc-G22 as adjunctive therapy to clotrimazole for preventing recurrence of vulvovaginal candidiasis (VVC). One hundred women aged 18-50 years with a history of ≥2 VVC episodes and current positive fungal microscopy were randomized 1:1 to receive clotrimazole vaginal tablets plus oral Lc-G22 (5×10⁹ CFU, twice daily for 60 days) or clotrimazole plus matching placebo. The primary outcome was overall clinical response rate at Month 3. Secondary outcomes included mycological negativity rate, VVC clinical scores, vaginal microecological parameters, and cumulative recurrence rate over 12 months. Safety was assessed by adverse event incidence.
- Conditions
- Vulvovaginal Candidiasis
- Being tested
- Lactobacillus crispatus Lc-G22, Placebo
- Keywords
- Vulvovaginal candidiasis, Lactobacillus crispatus, probiotic, randomized controlled trial, recurrence, clotrimazole, vaginal microbiome, Lc-G22
- Medical subject headings
- Candidiasis, Vulvovaginal, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus crispatus Lc-G22Dietary supplement
Oral capsules containing 5×10⁹ CFU live Lactobacillus crispatus Lc-G22 (lyophilized powder), provided by BIOGROWING CO., LTD. One capsule twice daily with meals for 60 consecutive days.
PlaceboDietary supplement
Oral capsules containing maltodextrin, identical in appearance to Lc-G22 capsules. Same dosing schedule: one capsule twice daily for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Lc-G22 Probiotic Group | Experimental | Participants received oral capsules containing live Lactobacillus crispatus Lc-G22 (5×10⁹ CFU per capsule, twice daily with meals for 60 consecutive days) plus intravaginal clotrimazole 500 mg on Days 1 and 4, followed by once-weekly clotrimazole 500 mg for 8 weeks. Receives: Dietary Supplement: Lactobacillus crispatus Lc-G22 |
| Placebo Control Group | Placebo comparator | Participants received identical-appearing oral placebo capsules (maltodextrin, twice daily with meals for 60 consecutive days) plus intravaginal clotrimazole 500 mg on Days 1 and 4, followed by once-weekly clotrimazole 500 mg for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Clinical Response Rate at Month 3
Proportion of participants achieving cure or marked improvement at 3 months after treatment initiation. Cure was defined as complete resolution of symptoms and signs, negative fungal microscopy, and symptom reduction rate of 100%. Marked improvement was defined as significant improvement, negative fungal microscopy, and symptom reduction rate of 80-99%. Symptom reduction rate = [(Baseline VVC score - Follow-up VVC score) / Baseline VVC score] × 100%.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Jul 2022
- Primary completion15 Dec 2023
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal CandidiasisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGrowing Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727967
- Sponsor's protocol ID
- [2021] LunShen-046
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data. Requests for de-identified data may be considered upon reasonable scientific request to the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Lactobacillus Crispatus Lc-G22 as Adjunctive Therapy to Clotrimazole for Preventing Recurrence of Vulvovaginal Candidiasis: A Single-Center, Randomized, Single-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07727967
- Acronym / sponsor ID
- [2021] LunShen-046
- Conditions
- Vulvovaginal Candidiasis
- Keywords
- Vulvovaginal candidiasis, Lactobacillus crispatus, probiotic, randomized controlled trial, recurrence, clotrimazole, vaginal microbiome, Lc-G22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BioGrowing Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 27 Jul 2026 (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.
This single-center, randomized, single-blind, placebo-controlled trial aimed to evaluate the efficacy and safety of oral Lactobacillus crispatus Lc-G22 as adjunctive therapy to clotrimazole for preventing recurrence of vulvovaginal candidiasis (VVC). One hundred women aged 18-50 years with a history of ≥2 VVC episodes and current positive fungal microscopy were randomized 1:1 to receive clotrimazole vaginal tablets plus oral Lc-G22 (5×10⁹ CFU, twice daily for 60 days) or clotrimazole plus matching placebo. The primary outcome was overall clinical response rate at Month 3. Secondary outcomes included mycological negativity rate, VVC clinical scores, vaginal microecological parameters, and cumulative recurrence rate over 12 months. Safety was assessed by adverse event incidence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lc-G22 Probiotic Group | Experimental | Dietary Supplement: Lactobacillus crispatus Lc-G22Participants received oral capsules containing live Lactobacillus crispatus Lc-G22 (5×10⁹ CFU per capsule, twice daily with meals for 60 consecutive days) plus intravaginal clotrimazole 500 mg on Days 1 and 4, followed by once-weekly clotrimazole 500 mg for 8 weeks. |
| Placebo Control Group | Placebo comparator | Dietary Supplement: PlaceboParticipants received identical-appearing oral placebo capsules (maltodextrin, twice daily with meals for 60 consecutive days) plus intravaginal clotrimazole 500 mg on Days 1 and 4, followed by once-weekly clotrimazole 500 mg for 8 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-50 years
- Female
- History of two or more clinically and mycologically confirmed vulvovaginal candidiasis episodes within the preceding 12 months
- Current episode with positive vaginal fungal microscopy (10% KOH wet mount)
- Presence of typical clinical symptoms (e.g., vulvar pruritus, abnormal vaginal discharge) and signs
Key exclusion criteria (7 listed)
- Severe psychiatric disorders
- Long-term (>4 weeks) use of systemic antibiotics, immunosuppressants, or corticosteroids
- Known allergy to clotrimazole or any component of the study product
- Diabetes mellitus
- Pregnancy or lactation
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 crispatus Lc-G22Oral capsules containing 5×10⁹ CFU live Lactobacillus crispatus Lc-G22 (lyophilized powder), provided by BIOGROWING CO., LTD. One capsule twice daily with meals for 60 consecutive days. | Dietary supplement | Lc-G22 Probiotic Group |
| PlaceboOral capsules containing maltodextrin, identical in appearance to Lc-G22 capsules. Same dosing schedule: one capsule twice daily for 60 days. | Dietary supplement | Placebo Control Group |
Primary outcome
Overall Clinical Response Rate at Month 3
Time frame: Month 3
Proportion of participants achieving cure or marked improvement at 3 months after treatment initiation. Cure was defined as complete resolution of symptoms and signs, negative fungal microscopy, and symptom reduction rate of 100%. Marked improvement was defined as significant improvement, negative fungal microscopy, and symptom reduction rate of 80-99%. Symptom reduction rate = [(Baseline VVC score - Follow-up VVC score) / Baseline VVC score] × 100%.
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 27 Jul 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data. Requests for de-identified data may be considered upon reasonable scientific request to the corresponding author
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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 Lactobacillus crispatus Lc-G22 in people with Vulvovaginal Candidiasis, run by BioGrowing 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 6 inclusion and 7 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 27 Jul 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?
Overall Clinical Response Rate at Month 3 (time frame: Month 3). 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 27 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.