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

NCT07603895 | Recruiting

• 1 other identifier: CVV.PROB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Vulvovaginal Candidiasis (VVC)

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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

  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

  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

  4 weeks

Other Outcomes (4)

• Number and severity of total adverse events reported by patients during the 4-week treatment period

  4 weeks

• Number and severity of adverse events potentially attributable to the study product during the 4-week treatment period

  4 weeks

• Changes in vaginal pH at the end of the 4-week intervention period between the study groups, compared with the baseline visit

  4 weeks

Study Arms (2)

Bioithas WOMAN®

EXPERIMENTAL

Dietary Supplement: Bioithas WOMAN®

Control group

NO INTERVENTION

Interventions

Bioithas WOMAN® DIETARY_SUPPLEMENT

≥1 × 10⁹ CFU of a probiotic blend composed of Lacticaseibacillus rhamnosus, Lactiplantibacillus plantarum, and Kluyveromyces marxianus

Bioithas WOMAN®

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify if:

• Pregnancy or breastfeeding.
• Menopause or perimenopause.
• Diabetes mellitus.
• 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.

Sponsors & Collaborators

• Bioithas SL: lead

Study Sites (1)

Hospital Universitario de Torrevieja

Torrevieja, Alicante, 03186, Spain

RECRUITING

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Central Study Contacts

Juan Gabriel Agüera Santos

CONTACT

623 02 25 86; juan.aguera@bioithas.com

Vicente Navarro López

CONTACT

vicente.navarrro@bioithas.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): May 25, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication and for 5 years thereafter
• Access Criteria: Access to the study data will be granted to qualified researchers upon justified request to the corresponding author

Locations

ES (1)