Vulvovaginal Candidiasis (VVC)NCT07603895
Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis
A study testing Bioithas WOMAN® in people with Vulvovaginal Candidiasis (VVC), run by Bioithas SL at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vulvovaginal Candidiasis (VVC)
- What is being tested?
- Bioithas WOMAN®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vicente Navarro López contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Torrevieja
Torrevieja, Alicante, 03186
Ana María Navarro Fenoll, 608 33 07 27, navarro_anafen@gva.es
Eduardo Cazorla Amorós, cazorla_edu@gva.es
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Vulvovaginal Candidiasis (VVC)
- Being tested
- Bioithas WOMAN®
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioithas WOMAN®Dietary supplement
≥1 × 10⁹ CFU of a probiotic blend composed of Lacticaseibacillus rhamnosus, Lactiplantibacillus plantarum, and Kluyveromyces marxianus
| Study group | Role | What they receive |
|---|---|---|
| Bioithas WOMAN® | Experimental | Not described Receives: Dietary Supplement: Bioithas WOMAN® |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (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.
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
Measured: 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
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
- = Mild
- = Moderate
- = 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.
Measured: 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
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
Measured: 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
For participants in the probiotic group, the remaining treatment will be collected to assess adherence during the treatment period
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start25 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal Candidiasis (VVC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioithas SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603895
- Sponsor's protocol ID
- CVV.PROB
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in the published article may be shared upon reasonable request, subject to approval by the sponsor and/or principal investigator, compliance with applicable data protection regulations, and execution of an appropriate data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT07603895
- Acronym / sponsor ID
- CVV.PROB
- Conditions
- Vulvovaginal Candidiasis (VVC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bioithas SLIndustry (pharma, biotech, devices)
- Study start
- 25 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioithas WOMAN® | Experimental | Dietary Supplement: Bioithas WOMAN® |
| Control group | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioithas WOMAN®≥1 × 10⁹ CFU of a probiotic blend composed of Lacticaseibacillus rhamnosus, Lactiplantibacillus plantarum, and Kluyveromyces marxianus | Dietary supplement | Bioithas WOMAN® |
Primary outcome
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
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results reported in the published article may be shared upon reasonable request, subject to approval by the sponsor and/or principal investigator, compliance with applicable data protection regulations, and execution of an appropriate data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vicente Navarro López contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioithas WOMAN® in people with Vulvovaginal Candidiasis (VVC), run by Bioithas SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Gabriel Agüera Santos (623 02 25 86, juan.aguera@bioithas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.