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 microbiological variables will be reassessed. Concomitant treatments, relevant follow-up observations, and any adverse events reported during the study will also be recorded. In the probiotic group, adherence to treatment will be assessed by counting the remaining capsules.
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
Menstruation at the time of inclusion.
Pregnancy or breastfeeding.
Menopause or perimenopause.
Diabetes mellitus.
Parallel
Bioithas WOMAN®
Dietary supplement≥1 × 10⁹ CFU of a probiotic blend composed of Lacticaseibacillus rhamnosus, Lactiplantibacillus plantarum, and Kluyveromyces marxianus
Difference in the number and percentage of patients with complete absence of symptoms associated with VVC at the end of the 4-week treatment period between the study groups, compared with the baseline visit.
The complete absence of symptoms associated with VVC will be assessed. The symptoms evaluated will include: abnormal vaginal discharge, pruritus, burning sensation, irritation, and dyspareunia
Difference in the number and percentage of patients with absence of each individual symptom associated with VVC at the end of the 4-week treatment period between the study groups, compared with the baseline visit.
The absence of each symptom associated with VVC will be assessed separately. The symptoms evaluated will include: abnormal vaginal discharge, pruritus, burning sensation, irritation, and dyspareunia
Changes in the Vaginitis Symptom Score (VSS) at the end of the 4-week intervention period between the study groups, compared with the baseline visit
Vaginistis Symptom Score (VSS) is a clinical scale used to assess the presence and severity of symptoms associated with vulvovaginal candidiasis, based on the assessment of the main symptoms reported by the patient. The VSS includes the evaluation of the following symptoms: Abnormal vaginal discharge Vaginal pruritus Burning sensation Vaginal irritation Dyspareunia Each symptom is scored individually according to its intensity, using an ordinal severity scale, usually defined as: 0 = Absent 1. = Mild 2. = Moderate 3. = Severe The total VSS score is obtained as the sum of the individual scores for each symptom, resulting in a total range from 0 to 15 points, where higher values indicate greater severity of vaginal symptoms.
Difference in the number and percentage of patients with a negative vaginal culture for Candida at the end of the 4-week treatment period between the study groups, compared with those with an initially positive culture at the baseline visit
Among patients in whom the diagnosis of vulvovaginal candidiasis is microbiologically confirmed by a positive Candida culture result, a follow-up culture will be performed at 4 weeks to assess culture negativization after the administered treatment
Adherence to the investigational product based on the count of capsules returned at the end of the treatment period among participants in the probiotic group
For participants in the probiotic group, the remaining treatment will be collected to assess adherence during the treatment period
Number and severity of total adverse events reported by patients during the 4-week treatment period
All adverse events occurring during the study follow-up period will be collected
Number and severity of adverse events potentially attributable to the study product during the 4-week treatment period
Adverse events potentially attributable to the study product will be collected during the follow-up period, especially those of a digestive nature
Changes in vaginal pH at the end of the 4-week intervention period between the study groups, compared with the baseline visit
Vaginal pH will be measured using an indicator strip at the beginning and end of the study, with the aim of assessing possible changes after 4 weeks of follow-up
Changes in the vaginal load of Lactobacillus spp. at the end of the 4-week treatment period between the study groups, compared with the baseline visit.
Changes in the vaginal load of Lactobacillus spp. will be assessed by semiquantitative colony count (CFU) obtained through microbiological culture on selective medium
Click on the lead sponsor to view all of their trials.
