Clinical trial NCT04699240: Study of Lactobacillus in Adjuvant Treatment of RVVC
Official title: A Prospective, Case-controlled Randomized Study of Human Reproductive Tract Active Lactobacillus in Adjuvant Treatment of Recurrent Vulvovaginal Candidiasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrent Vulvovaginal Candidiasis
Keywords: Recurrent Vulvovaginal Candidiasis
Lactobacillus
reproductive tract flora
Lead sponsor: Peking University Shenzhen Hospital
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: The cure rate of RVVC,
timeFrame: 6 months
Secondary outcomes:
measure: Recurrence of RVVC
timeFrame: 6 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Dept Obstetrics and Gynecology
state: Guangdong
Study officials:
affiliation: Peking University Shenzhen Hospital
name: Shangrong Fan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: