Study of the Probiotic Bioithas WOMAN as Additional Treatment for Vulvovaginal Candidiasis in Women

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.

Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis