Oral Lactobacillus Crispatus Lc-G22 as Adjunctive Therapy for Vulvovaginal Candidiasis

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.

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Key information

Conditions

Vulvovaginal Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus crispatus Lc-G22

Dietary 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.

Placebo

Dietary Supplement

Oral capsules containing maltodextrin, identical in appearance to Lc-G22 capsules. Same dosing schedule: one capsule twice daily for 60 days.

Primary outcomes

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%.

Sponsors and collaborators

Lead sponsor

BioGrowing Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2024
First posted: Jul 27, 2026
Registry last updated: Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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