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

RecruitingNAAges any - anyFemaleBioithas SL
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Women of reproductive age who use effective contraceptive methods during the course of the study. * Clinical suspicion of vulvovaginal candidiasis, in the investigator's judgment, based on the presence of symptoms - e.g., pruritus, burning sensation, irritation, dyspareunia and/or abnormal vaginal discharge - and/or compatible clinical findings. * Possibility of collecting a vaginal sample at the baseline visit for microbiological analysis. * Ability and willingness to comply with the study procedures and to sign the informed consent form Exclusion Criteria: * Menstruation at the time of inclusion. * Pregnancy or breastfeeding. * Menopause or perimenopause. * Diabetes mellitus. * Presence of immunocompromised status or treatment with immunosuppressants within the 3 months prior to inclusion in the trial. * Vaginal coinfection in addition to vulvovaginal candidiasis. * Severe chronic diseases or other active infections that may interfere with the clinical assessment of vulvovaginal candidiasis, in the investigator's judgment. * History of intolerance or hypersensitivity to the intervention products. * Treatment with antifungals or probiotic supplements in the month prior to inclusion in the trial.
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What it tests

  • Bioithas WOMAN®
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Where

1 site
Hospital Universitario de Torrevieja
Torrevieja, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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