Actively Recruiting
Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis
Led by Bioithas SL · Updated on 2026-05-22
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the use of the probiotic supplement Bioithas WOMAN4 as an additional treatment alongside antifungal medication for women with clinically suspected vulvovaginal candidiasis (VVC). This open-label, randomized clinical trial includes a control group and focuses on evaluating symptom improvement and microbiological changes over a 4-week treatment period. The study aims to compare outcomes between women receiving only antifungal treatment and those also taking the probiotic supplement. Participants will be randomly assigned to either the treatment group, which receives the probiotic supplement in addition to prescribed antifungal therapy, or the control group, which receives antifungal treatment alone. The probiotic is provided as a bottle containing 30 capsules, taken during the 4-week intervention. The study includes two on-site visits: a baseline visit where clinical data and vaginal samples are collected, and a final visit at week 4, where the same assessments are repeated, including symptom scoring and microbiological cultures. During the study visits, researchers will collect demographic and gynecological history, record symptoms such as vaginal discharge, itching, burning, irritation, and pain during intercourse, and measure vaginal pH. Vaginal samples will be cultured to detect Candida and assess Lactobacillus levels. Treatment adherence in the probiotic group will be monitored by capsule counts. The main outcome measured is the difference in symptom absence after 4 weeks between groups, along with secondary outcomes like symptom scores, microbiological culture results, and adherence. Any adverse events and additional treatments during follow-up will also be recorded.
CONDITIONS
Brief Title
Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women of reproductive age who use effective contraceptive methods during the study
- Clinical suspicion of vulvovaginal candidiasis based on symptoms or clinical findings
- Ability to collect a vaginal sample at baseline for microbiological analysis
- Willingness and ability to comply with study procedures and sign informed consent
You will not qualify if you...
- Menstruation at the time of inclusion
- Pregnancy or breastfeeding
- Menopause or perimenopause
- Diabetes mellitus
- Immunocompromised status or immunosuppressant treatment within 3 months prior
- Vaginal coinfection besides vulvovaginal candidiasis
- Severe chronic diseases or active infections interfering with clinical assessment
- History of intolerance or hypersensitivity to study products
- Antifungal or probiotic treatment in the month prior to inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 4 weeks
Participants receive antifungal treatment with or without a probiotic supplement for vulvovaginal candidiasis.
1 baseline visit and 1 follow-up visit at Week 4
Trial Site Locations
Total: 1 location
1
Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain, 03186
Actively Recruiting
Research Team
J
Juan Gabriel Agüera Santos
V
Vicente Navarro López
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here