Condition: Vulvovaginal Candidiasis (VVC) · Sponsor: Bioithas SL
Open-label, randomized clinical trial with a control group and a 4-week intervention period. The study will evaluate the efficacy of the probiotic supplement Bioithas WOMAN® as an adjunctive treatment in women with clinically suspected vulvovaginal candidiasis (VVC). All participants will receive the antifungal treatment prescribed by the investigator. Participants allocated to the probiotic group will additionally receive Bioithas WOMAN®, supplied as a bottle containing 30 capsules, to be taken during the 4-week intervention period. The study includes two on-site visits: Visit 1 (baseline) and Visit 2 (week 4/end of study). At baseline, demographic data, relevant gynecological history, VVC risk factors, clinical characteristics of the current episode, concomitant diseases, and usual pharmacological treatments will be recorded. Clinical symptoms associated with VVC, including abnormal vaginal discharge, pruritus, burning sensation, irritation, and dyspareunia, will be assessed, together with the Vaginitis Symptom Score (VSS). At both visits, vaginal pH will be measured using an indicator strip applied to the vaginal mucosa. A vaginal sample will also be collected using a sterile swab for microbiological culture of Candida and semiquantitative assessment of Lactobacillus. Although randomization will be performed in women with clinical suspicion of VVC, microbiological confirmation by culture will be obtained after inclusion. At the final visit, the same clinical and microb…
This description comes directly from the study's public registry record.
Juan Gabriel Agüera Santos · 623 02 25 86 · juan.aguera@bioithas.com
Vicente Navarro López · vicente.navarrro@bioithas.com
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| Hospital Universitario de Torrevieja | Torrevieja, Alicante, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07603895