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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall Clinical Response Rate at Month 3
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-50 years
- •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
排除标准
- •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
结局指标
主要结局
Overall Clinical Response Rate at Month 3
时间窗: 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%.
次要结局
未报告次要终点