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Completed

NCT Number: NCT04699240

Study of Lactobacillus in Adjuvant Treatment of RVVC

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Taking / injecting antibiotics in the past two weeks;
  • A woman who intends to be pregnant, pregnant or lactating;
  • Long term use of contraceptives and immunosuppressants;
  • Postmenopausal;
  • There was no same fixed sexual partner (RSP) before and after treatment
  • 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;
  • 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.)

Treatment and study plan

clotrimazole vaginal tablets

Drug

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

Other names: clotrimazole vaginal tablets(Bayer)

Clotrimazole vaginal tablets+ Lactobacillus

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

Other names: Clotrimazole vaginal tablets+ Lactobacillus(Umeta-mimi)

Primary outcomes

  1. The cure rate of RVVC,

    Time frame: 6 months

    The cure rate of RVVC,

Secondary outcomes

  1. Recurrence of RVVC

    Time frame: 6 months

    Recurrence of RVVC

Sponsors and collaborators

Lead sponsor

Peking University Shenzhen Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 7, 2021
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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