Study of Lactobacillus in Adjuvant Treatment of RVVC

Phase 4

Recruiting

• Conditions: Recurrent Vulvovaginal Candidiasis
• Interventions: Drug: Clotrimazole vaginal tablets+ Lactobacillus; Drug: clotrimazole vaginal tablets

• Registration Number: NCT04699240
• Lead Sponsor: Peking University Shenzhen Hospital

Brief 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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• Women be at least 18 years of age
• Have symptoms of vulva irritation and or abnormal discharge
• Meet the clinical criteria for RVVC
• Willing to participate in research

Exclusion Criteria

1. Taking / injecting antibiotics in the past two weeks;
2. A woman who intends to be pregnant, pregnant or lactating;
3. Long term use of contraceptives and immunosuppressants;
4. Postmenopausal;
5. There was no same fixed sexual partner (RSP) before and after treatment
6. Patients with severe gastrointestinal diseases, including colorectal cancer, IBS, IBD, chronic or acute diarrhea, long-term constipation, etc., or receiving gastrointestinal surgery and abdominal surgery within one year, such as cholecystectomy;
7. Patients with severe heart, liver and kidney dysfunction, mental diseases, infectious diseases, tumors, severe anemia, and severe autoimmune diseases (such as rheumatoid arthritis, lupus erythematosus, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clotrimazole vaginal tablets+ Lactobacillus	Clotrimazole vaginal tablets+ Lactobacillus	Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times + Lactobacillus Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months
Clotrimazole vaginal tablets	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

Primary Outcome Measures

Name	Time	Method
The cure rate of RVVC,	6 months	The cure rate of RVVC,

Secondary Outcome Measures

Name	Time	Method
Recurrence of RVVC	6 months	Recurrence of RVVC

Trial Locations

Locations (1)

Dept Obstetrics and Gynecology; 🇨🇳 Shenzhen, Guangdong, China