Vulvovaginal candidiasis Infections and Infestations
Conditions
Interventions
Participants will consume one capsule daily of either a probiotic formulation (L. plantarum DSM24937, L. rhamnosus DSM 25568, and B. animalis subsp. lactis DSM25566) or a placebo, according to their r
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Sponsors
SynBalance SRL
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Female 2. Aged between 18 and 45 years 3. Capable of understanding and signing the informed consent 4. Capable of understanding and complying with the protocol requirements 5. Negative pregnancy test 6. Negative HIV test 7. Who are not taking, and will not take, any type of medication throughout the study period, except for antifungal treatment for Candida spp. infection, when necessary 8. Who have a history of recurrent vulvovaginal candidiasis (RVVC), defined as three or more Candida spp. infections in less than 1 year 9. Who present with a vulvovaginal Candida spp. infection at the screening phase, confirmed by microbiological culture
Exclusion criteria
Exclusion criteria: 1. Male 2. Age 45 years 3. Pregnant, suspected to be pregnant, or planning to become pregnant during the study period 4. In the lactation phase 5. Not self-sufficient 6. Who are unwilling to cooperate 7. Who have difficulty attending the study site within the scheduled times 8. Who are deemed ineligible by the investigator due to the presence of other conditions considered incompatible with enrollment and requiring pharmacological treatments 9. Diagnosed with acquired immunodeficiency from HIV 10. With known allergies to the ingredients of the experimental products (active or placebo) 11. Who have other vulvovaginal infections unrelated to Candida spp. 12. Who abuse alcohol, drugs, nicotine, caffeine, or theine To ensure homogeneous distribution of the type of contraceptive method used by the study participants across the two experimental groups, randomization will be conducted in such a way that both groups will have a similar number of women using oral contraceptives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of recurrent and symptomatic vulvovaginal Candida spp. infections and the need for antifungal treatment. The Candida spp infection is confirmed through a vulvovaginal swab and the need for the antifungal treatment is determined by medical assessment whenever the participants visit the experimental center if they experience at least one typical symptom of candidiasis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptoms of recurrent candidiasis measured using the Sobel scale at baseline (T0), at the end of the maintenance period (T5), and at each recurrence onset 2. Pro-inflammatory cytokine profile (IL-17, IL-6, TNF-a) evaluated using swab at baseline (t0) and at the end of the maintenance period (t5) 3. Vulvovaginal microbiome evaluated using swab and eNAT at baseline (t0) and at the end of the maintenance period (t5) 4. Quality of life measured using the Short Form-12 (SF-12) questionnaire at baseline (T0), at the end of the maintenance period (T5), 28 days after the end of the treatment (follow-up – TFW), and at each occurrence of recurrence | — |
Countries
Italy
Contacts
Public ContactLorenza Francesca;Alessandra De Lellis;Baldi
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Outcome results
None listed