Vulvovaginal Candidiasis
Conditions
Keywords
Vulvovaginal candidiasis, Lactobacillus crispatus, probiotic, randomized controlled trial, recurrence, clotrimazole, vaginal microbiome, Lc-G22
Brief 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). 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.
Interventions
DIETARY_SUPPLEMENTLactobacillus crispatus Lc-G22
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.
DIETARY_SUPPLEMENTPlacebo
Oral capsules containing maltodextrin, identical in appearance to Lc-G22 capsules. Same dosing schedule: one capsule twice daily for 60 days.
Sponsors
BioGrowing Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Clinical Response Rate at Month 3 | 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%. |
Countries
China
Outcome results
None listed