Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bioithas WOMAN®.
- Who it may be relevant to
- Registry conditions: Vulvovaginal Candidiasis (VVC). Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Dietary supplement Bioithas WOMAN®
≥1 × 10⁹ CFU of a probiotic blend composed of Lacticaseibacillus rhamnosus, Lactiplantibacillus plantarum, and Kluyveromyces marxianus
Primary outcome measures
- 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. [Time frame: 4 weeks]
Secondary outcome measures (4)
- 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. [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 4 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Universitario de Torrevieja — Torrevieja
Identifiers
NCT: NCT07603895 · CVV.PROB