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

18. maj 2026 opdateret af: Bioithas SL

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Spanien
    • Alicante
      • Torrevieja, Alicante, Spanien, 03186
        • Rekruttering
        • Hospital Universitario de Torrevieja
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Eduardo Cazorla Amorós, MD
        • Underforsker:
          • Duska Beric, MD
        • Underforsker:
          • Elisa Peñalver Escolano, MD
        • Underforsker:
          • Ana María Navarro Fenoll, SN

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Kontrolgruppe
Eksperimentel: Bioithas WOMAN®
Kosttilskud: Bioithas WOMAN®
≥1 × 10⁹ CFU of a probiotic blend composed of Lacticaseibacillus rhamnosus, Lactiplantibacillus plantarum, and Kluyveromyces marxianus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 4 weeks
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
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
Tidsramme: 4 weeks

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.
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
Tidsramme: 4 weeks
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
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
Tidsramme: 4 weeks
For participants in the probiotic group, the remaining treatment will be collected to assess adherence during the treatment period
4 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number and severity of total adverse events reported by patients during the 4-week treatment period
Tidsramme: 4 weeks
All adverse events occurring during the study follow-up period will be collected
4 weeks
Number and severity of adverse events potentially attributable to the study product during the 4-week treatment period
Tidsramme: 4 weeks
Adverse events potentially attributable to the study product will be collected during the follow-up period, especially those of a digestive nature
4 weeks
Changes in vaginal pH at the end of the 4-week intervention period between the study groups, compared with the baseline visit
Tidsramme: 4 weeks
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
4 weeks
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.
Tidsramme: 4 weeks
Changes in the vaginal load of Lactobacillus spp. will be assessed by semiquantitative colony count (CFU) obtained through microbiological culture on selective medium
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bioithas SL

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

25. maj 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CVV.PROB

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Beginning 6 months after publication and for 5 years thereafter

IPD-delingsadgangskriterier

Access to the study data will be granted to qualified researchers upon justified request to the corresponding author

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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Kliniske forsøg med Vulvovaginal candidiasis (VVC)

Kliniske forsøg med Bioithas WOMAN®

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