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Tests treatment safety and results for Vulvovaginal Candidiasis (VVC)
Official title Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis
ClinicalTrials.gov ID: NCT07603895
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, women only
You may be able to join if
- 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...
- 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
You likely can't join if
- 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.
See the full eligibility 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Torrevieja, Alicante, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Torrevieja, Alicante, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.