Bioithas WOMAN as an added treatment for vulvovaginal candidiasis
Official title: Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis
Run by Bioithas SL · NCT07603895 · Data updated 2026-11-12
We’re testing whether adding Bioithas WOMAN probiotic to standard antifungal treatment helps women with vulvovaginal candidiasis.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Bioithas SL Industry-sponsored |
| Locations | 1 site (Torrevieja, Alicante) |
| Status | Recruiting |
| Started | May 25, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT07603895 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women of reproductive age with clinical suspicion of VVC, willing to use contraception during the study, and able to provide a baseline vaginal sample.
✕Probably not a fit
Participants whose symptoms do not improve or worsen despite probiotic use and antifungal therapy may not experience additional benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, randomized study compares standard antifungal therapy alone versus antifungal therapy plus Bioithas WOMAN probiotic over 4 weeks in women suspected of having vulvovaginal candidiasis. Participants are assigned to receive the probiotic in addition to their usual treatment and are followed with two on-site visits: at baseline and at week 4. Outcomes focus on the status of vulvovaginal symptoms and clinical characteristics during the intervention period. All participants receive the antifungal medication prescribed by the investigator, with the probiotic group also taking a 30-count bottle of Bioithas WOMAN during the 4 weeks. Eligibility includes reproductive-age women using contraception, with clinical suspicion of VVC and ability to provide a vaginal sample at baseline.
Why it matters
Potential benefit: If successful, the probiotic could provide additional symptom relief and potentially improve treatment outcomes for VVC.
How similar studies have gone: Previous studies in this area have explored probiotics as adjuncts to antifungals with mixed results; this study adds data from Bioithas WOMAN in an open-label design.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Hospital Universitario de Torrevieja
Torrevieja, Alicante, Spain Recruiting
Study contacts
- Study coordinator: Juan Gabriel Agüera Santos
- Email: juan.aguera@bioithas.com
- Phone: 623 02 25 86
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.