The beneficial effect on candidiasis of a food supplement based on a formulation of probiotics
| ISRCTN | ISRCTN10719217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10719217 |
| ClinicalTrials.gov (NCT) | Not applicable |
| Clinical Trials Information System (CTIS) | Not applicable |
| Integrated Research Application System (IRAS) | Not applicable |
| Protocol serial number | FSYNRVVC24_01 |
| Sponsor | SynBalance SRL |
| Funder | SYNBALANCE Srl |
- Submission date
- 12/01/2026
- Registration date
- 22/01/2026
- Last edited
- 23/01/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
A probiotic dietary supplement containing L. plantarum PBS067, L. rhamnosus LRH020, and B. animalis subsp. lactis BL050 may have a positive impact on the vaginal microbiota. The aim of this study is to demonstrate that this dietary supplement reduces the incidence of vulvovaginal Candida spp. infections and manages the symptoms of candidiasis in women of reproductive age.
Who can participate?
Women aged between 18 and 45 years with a vulvovaginal Candida spp. infection and a history of recurrent vulvovaginal candidiasis, defined as three or more Candida spp. infections in less than 1 year
What does the study involve?
Participants will be randomly allocated to consume one capsule daily of either the supplement or a placebo (dummy). After an initial 2-week treatment period and a subsequent 2-week washout phase, participants will enter a 4-month 'maintenance phase' during which they will take the supplement or placebo for only 1 week per month. Throughout the entire treatment period, participants must visit the study center if they experience one or more symptoms of candidiasis. During the medical visit, a medical evaluation will be conducted to determine the need for antifungal treatment.
What are the possible benefits and risks of participating?
An improvement in the incidence of recurrent symptomatic vulvovaginal infections due to Candida spp., and therefore a reduction in the need for antifungal treatment, is expected following the administration of the supplement. However, it is possible that no benefit will be observed.
Where is the study run from?
COMEGEN Soc. Coop. Sociale (Italy)
When is the study starting and how long is it expected to run for?
January 2026 to July 2026
Who is funding the study?
SynBalance SRL (Italy)
Who is the main contact?
1. Alessandra Baldi, alessandra.baldi.alimenti@gmail.com
2. Lorenza Francesca De Lellis, lo.delellis2@gmail.com
Contact information
Public, Scientific
Via Domenico Montesano
Naples
80131
Italy
| Phone | +39 (0)3883810763 |
|---|---|
| lo.delellis2@gmail.com |
Public
Viale delle Medaglie d’oro, 305
Rome
0136
Italy
| Phone | +39 (0)3483854114 |
|---|---|
| alessandra.baldi.alimenti@gmail.com |
Principal investigator
Viale Maria Bakunin, 41
Naples
80126
Italy
| Phone | +39 (0)3939406629 |
|---|---|
| comegen@comegen.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Monocentric randomized placebo-controlled double-blind trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Efficacy study of a food supplement based on a formulation of probiotics on the incidence of recurrent symptomatic vulvo-vaginal infections from Candida spp. and on the management of candidiasis symptoms, in women of childbearing age to recurrent vulvovaginal candidiasis: single-centre, randomized, placebo-controlled, double-blind clinical study |
| Study acronym | FSYNRVVC24 |
| Study objectives | The intake of a dietary supplement containing Lactobacillus plantarum PBS067, Lactobacillus rhamnosus LRH020 and Bifidobacterium animalis subs. lactis BL050 has been hypothesized to have a positive impact on the vaginal microbiota. Therefore, the aim of this efficacy study is to demonstrate that the dietary supplement under study is effective in reducing the incidence of symptomatic recurrent vulvovaginal Candida spp. infections and in managing the symptoms of candidiasis in women of reproductive age with recurrent vulvovaginal candidiasis. |
| Ethics approval(s) |
Approved 17/12/2024, Ethics committee of CAMPANIA 1 (Via Mariano Semmola 53, Napoli, 80131, Italy; +39 (0)8117770131; comitatoetico@istitutotumori.na.it), ref: 6/24 |
| Health condition(s) or problem(s) studied | Vulvovaginal candidiasis |
| Intervention | 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 randomization group. To mantain the double-blind design, both treatments (food supplements and placebo) will be made unrecognizable as the packaging will be identical, and the dosage forms will be the same in color, shape, weight and taste. After an initial 2-week treatment period and a subsequent 2-week washout phase, participants will enter a 4-month 'maintenance phase' during which they will take the supplement or placebo for only 1 week per month. Throughout the entire treatment period, participants must visit the study center if they experience one or more symptoms of candidiasis. During the medical visit, a medical evaluation will be conducted to determine the need for antifungal treatment (vulvovaginal swab to confirm Candida spp. infection), and the Sobel scale and the SF-12 questionnaire will be administered. The study will evaluate the difference between the percentages observed in the two study groups of participants: "responders" (those who did not require antifungal treatment for symptomatic vulvovaginal Candida spp. infections during the 5-month study period, or who only needed antifungal treatment once for symptomatic vulvovaginal Candida spp. infections during the 5-month study period) and "non-responders" (those who required antifungal treatment more than once for symptomatic vulvovaginal Candida spp. infections during the 5-month study period). A secondary exploratory analysis will be conducted to estimate the percentage of participants falling into the following categories: "responder" (no Candida spp. infection during the 5-month study period); "partial responder" (one Candida spp. infection during the 5-month study period); "no responder" (two or more Candida spp. infections during the 5-month study period). |
| Intervention type | Supplement |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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 |
| Completion date | 26/07/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target sample size at registration | 82 |
| Key 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 |
| Key exclusion criteria | 1. Male 2. Age <18 years and > 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. |
| Date of first enrolment | 23/01/2026 |
| Date of final enrolment | 26/01/2026 |
Locations
Countries of recruitment
- Italy
Study participating centre
Naples
80126
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication. |
Editorial Notes
12/01/2026: Study's existence confirmed by SYNBALANCE Srl.
