NCT04699240

Study of Lactobacillus in Adjuvant Treatment of RVVC

A Prospective, Case-controlled Randomized Study of Human Reproductive Tract Active Lactobacillus in Adjuvant Treatment of Recurrent Vulvovaginal Candidiasis.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Peking University Shenzhen Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 52 Years
• Healthy volunteers: Not accepted

Summary

We are trying to determine if Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis

Detailed description

vulvovaginal candidiasis is common disease in women. Its refractory and high recurrence rate has always been a clinical problem. Some cases even recur several times a year, and those who recur more than four times a year are diagnosed as recurrent vaginal candidal infection Candidiasis, RVVC）。 The common clinical regimen for VVC is to strengthen and consolidate clotrimazole vaginal tablets for up to 25 weeks. However, long-term antibiotic treatment will lead to the decrease of vaginal microflora and the disappearance of inflammation and pathogenic bacteria, which will greatly increase the probability of repeated infection and become a barrier to clinical treatment. If probiotics are added in the treatment, the abundance of lactobacillus can be ensured while antibiotic treatment is carried out, the homeostasis of reproductive tract flora can be reestablished, the defense mechanism can be improved fundamentally, and the re invasion of pathogenic bacteria can be reduced, which will become a new treatment idea and method for radical cure of refractory RVVC. We hypothesize that Clotrimazole vaginal tablets with oral Lactobacillus is better than Clotrimazole vaginal tablets in Preventing the Recurrence of vulvovaginalcandidiasis.

Conditions

• Recurrent Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DRUG	clotrimazole vaginal tablets	Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months
DRUG	Clotrimazole vaginal tablets+ Lactobacillus	Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months Human Reproductive Tract Active Lactobacillus,4g,qd ,3months

Timeline

• Start date: 2020-07-01
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2021-01-07
• Last updated: 2025-06-12

Locations

1 site across 1 country: China