Study of Lactobacillus in Adjuvant Treatment of RVVC

Recurrent Vulvovaginal Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699240
• Other study ID #: pkuszh-2020-02
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Peking University Shenzhen Hospital
• Contact: yiheng liang, M.D.
• Phone: 86-755-83923333
• Email: liangyiheng.cn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Recurrence
• Recurrent Vulvovaginal Candidiasis

Intervention

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
• 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

Locations

Country	Name	City	State
China	Dept Obstetrics and Gynecology	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cure rate of RVVC,	The cure rate of RVVC,	6 months
Secondary	Recurrence of RVVC	Recurrence of RVVC	6 months