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

NCT07727967 | Completed

• 1 other identifier: [2021] LunShen-046
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvovaginal Candidiasis

Keywords

Vulvovaginal candidiasis; Lactobacillus crispatus; probiotic; randomized controlled trial; recurrence; clotrimazole; vaginal microbiome; Lc-G22

Outcome Measures

Primary Outcomes (1)

• 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%.

  Month 3

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

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.

Lc-G22 Probiotic Group

Placebo DIETARY_SUPPLEMENT

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

Placebo Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioGrowing Co., Ltd: lead

Study Sites (1)

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Recurrence

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 27, 2026
• Study Start: July 1, 2022
• Primary Completion: December 15, 2023
• Study Completion: October 31, 2024
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)