Study of Lactobacillus in Adjuvant Treatment of RVVC

NCT ID: NCT04699240

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2023-12-30

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.

Conditions

Recurrent Vulvovaginal Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

clotrimazole vaginal tablets

Intervention Type: DRUG

Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months

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

Group Type: ACTIVE_COMPARATOR

Clotrimazole vaginal tablets+ Lactobacillus

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

clotrimazole vaginal tablets（Bayer）; Clotrimazole vaginal tablets+ Lactobacillus（Umeta-mimi）

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Shenzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shangrong Fan

Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shangrong Fan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Shenzhen Hospital

Locations

Dept Obstetrics and Gynecology

Shenzhen, Guangdong, China

Countries

China

Other Identifiers

pkuszh-2020-02

Identifier Type: -

Identifier Source: org_study_id