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 ā„2 VVC episodes and current positive fungal microscopy were randomized 1:1 to receive clotrimazole vaginal tablets plus oral Lc-G22 (5Ć10ā¹ 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.
Inclusion Criteria:
Exclusion Criteria:
Participants received oral capsules containing live Lactobacillus crispatus Lc-G22 (5Ć10ā¹ 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.
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.
Guangzhou, Guangdong, China
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