Study of Lactobacillus in Adjuvant Treatment of RVVC

Peking University

Status and phase: Enrolling; Phase 4

Conditions: Recurrent Vulvovaginal Candidiasis

Treatments: Drug: Clotrimazole vaginal tablets+ Lactobacillus; Drug: clotrimazole vaginal tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT04699240

pkuszh-2020-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18 to 52 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Clotrimazole vaginal tablets

Active Comparator group

Description:

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

Treatment:

Drug: clotrimazole vaginal tablets

Clotrimazole vaginal tablets+ Lactobacillus

Active Comparator group

Description:

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

Treatment:

Drug: Clotrimazole vaginal tablets+ Lactobacillus