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

Open-label, randomized clinical trial with a control group and a 4-week intervention period.

During the study, 2 on-site visits will be carried out:

Visit 1 (V1) - Study start: Inclusion of cases and controls Visit 2 (V2) - End of study: Week 4 of treatment and follow-up

The procedures performed at each visit are described below:

Visit 1 (V1) - Study start

Participation in the study will be proposed to patients attending the Gynecology outpatient clinics of Torrevieja University Hospital with a clinical suspicion, in the investigator's judgment, of vulvovaginal candidiasis (VVC). The investigator will provide them with the patient information sheet so that potential participants can understand the study procedures and objectives after carefully reading it, as well as ask any questions that may arise.

If the participant expresses interest in taking part in the study, she will be given two copies of the informed consent form to complete and sign, so that her willingness to participate in the study is duly documented.

After this, all inclusion and exclusion criteria will be checked one by one, so that the volunteer may ultimately participate in the study if all inclusion criteria and none of the exclusion criteria are met. At that point, she will be assigned a clinical trial participant number in order of inclusion, by which she will be identified.

The following data will be collected in the Case Report Form (CRF):

* Demographic data: age, BMI, concomitant diseases, and usual pharmacological treatments. * Clinical characteristics of the VVC episode: predominant symptoms, severity of the clinical condition, and prescribed antifungal treatment. * Relevant gynecological history and VVC risk factors.

The clinical variables under study will be collected:

\- Presence or absence (yes/no) of the usual symptoms associated with VVC: Abnormal vaginal discharge Pruritus Burning sensation Irritation Dyspareunia

* Vaginitis Symptom Score (VSS) * In addition, vaginal pH will be measured using a pH indicator strip applied to the vaginal mucosa. * A vaginal sample will also be collected for microbiological culture of Candida and culture for semiquantitative assessment of Lactobacillus.

The vaginal sample will be collected using a sterile swab. The swab will be rubbed and rotated over the vaginal mucosa to obtain secretion. The collected sample will be placed in the transport medium indicated by the center's laboratory, appropriately labeled, and sent for microbiological culture of Candida and Lactobacillus following the laboratory's standard procedures.

According to the randomization list, participants will be assigned to either the treatment group or the control group. Randomization will be performed in patients with clinical suspicion of VVC, although microbiological confirmation by culture will be carried out after inclusion.

Participants assigned to the treatment group will be provided with a bottle containing 30 capsules of the probiotic supplement Bioithas WOMAN®, which they will add to the antifungal treatment prescribed at the visit, whereas participants in the control group will receive only the antifungal treatment.

Visit 2 (V2) - End of study

As in Visit 1, the clinical variables under study will be collected:

* Presence or absence of the usual symptoms associated with vaginitis * Vaginitis Symptom Score (VSS)

In addition, the following will be performed:

* Vaginal pH measurement * Vaginal sample for microbiological culture of Candida and culture for semiquantitative assessment of Lactobacillus

Additionally, concomitant treatments and relevant observations during the follow-up period will be recorded, as well as any reported adverse events.

For participants in the probiotic group, treatment adherence will be assessed by counting the remaining capsules.

• 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. [Срок оценки: 4 weeks]
• 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 [Срок оценки: 4 weeks]
• 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 [Срок оценки: 4 weeks]
• 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 [Срок оценки: 4 weeks]