Recurrent Vulvovaginal CandidiasisNCT04639544
Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis
A study testing Lactobacillus strain in people with Recurrent Vulvovaginal Candidiasis, run by Biosearch S.A. at 1 site in Spain.
Trial summary
The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Vulvovaginal Candidiasis
- What is being tested?
- Lactobacillus strain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women from 18 to 49 years old.
- Having suffered at least four outbreaks of vaginal yeast infection in the last year.
- Signed Informed Consent Form.
- Agree to provide the scheduled samples.
- Agree to perform gynecological examinations
- Agree to report candidiasis events that occur during the study.
- Ability to complete surveys.
Who cannot join
- Being currently consuming or having consumed a probiotic in the two weeks prior to the study.
- Being under antibiotic treatment at the time of beginning the study.
- Being under pharmacological treatment for the treatment of candidiasis.
- Have an allergy to an antibiotic
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Infanta Elena
Valdemoro, Madrid, 28342
Cristina Fernandez Romero, M.D.
About this study
Official title: Randomized, Triple-blind, Parallel-group Study to Evaluate the Effect of Consuming a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis
The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.
Read the detailed description
Previous studies have demonstrated the effectiveness of certain probiotic strains in the treatment of vaginal candidiasis, alone or as an adjunct to antifungal treatments, as well as the effectiveness of a Lactobacillus strain as maintenance treatment after antifungal treatment to reduce the recurrence rate of candidiasis However, to date, no studies have evaluated the oral efficacy of a probiotic strain of Lactobacillus originally isolated from breast milk in the prevention of new vaginal yeast events in women with recurrent vaginal yeast infections.
The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Being tested
- Placebo, Lactobacillus strain
- Keywords
- Recurrent Vulvovaginal Candidiasis, Prevention, Probiotics
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
Lactobacillus strainDietary supplement
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Volunteers will take 1 capsule per day with maltodextrin for 6 months Receives: Dietary Supplement: Placebo |
| Probiotic group | Experimental | Volunteers will take 1 capsule per day with the Lactobacillus strain for 6 months Receives: Dietary Supplement: Lactobacillus strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of candidiasis events
Total candidiasis events during intervention
Measured: 6 months
Time between episodes
Days from baseline until candidiasis events
Measured: 6 months
Secondary outcomes (6)
Determination of Candida in vaginal exudate by culture analysis
Analysis of the presence of Candida in vaginal exudate
Measured: 6 months
Microbiota of vaginal exudate
Load of Candida, Lactobacillus, Gardnerella, Prevotella, Streptococcus and Bacteroides species in vaginal exudate samples
Measured: 6 months
Gynecological examination
The gynecologist will perform a gynecological examination to check:Presence of erythema of the vulva, erythema of the vaginal mucosa, lumpy, whitish-coloured vulvar oedema and excoriation of the vulva
Measured: 6 months
pH of vaginal discharge
Measurement of the pH of vaginal discharge
Measured: 6 months
Test of related clinical symptoms
The volunteers will complete a test about presence of vaginal itching, vaginal burning, whitish vaginal discharge, dysuria and dyspareunia.
Measured: 6 months
Intensity of the related clinical symptoms
Intensity (mild, moderate, intense) of the related clinical symptoms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start15 Feb 2021 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Vulvovaginal CandidiasisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Maldonado Lobón, PhD, Principal investigator, Biosearch S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639544
- Sponsor's protocol ID
- P049
- Status last verified
- Jan 2021
- First submitted
- 16 Oct 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Triple-blind, Parallel-group Study to Evaluate the Effect of Consuming a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis
- ClinicalTrials.gov ID
- NCT04639544
- Acronym / sponsor ID
- P049
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Keywords
- Recurrent Vulvovaginal Candidiasis, Prevention, Probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2021 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Nov 2020 (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.
The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.
Detailed description
Previous studies have demonstrated the effectiveness of certain probiotic strains in the treatment of vaginal candidiasis, alone or as an adjunct to antifungal treatments, as well as the effectiveness of a Lactobacillus strain as maintenance treatment after antifungal treatment to reduce the recurrence rate of candidiasis However, to date, no studies have evaluated the oral efficacy of a probiotic strain of Lactobacillus originally isolated from breast milk in the prevention of new vaginal yeast events in women with recurrent vaginal yeast infections.
The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: PlaceboVolunteers will take 1 capsule per day with maltodextrin for 6 months |
| Probiotic group | Experimental | Dietary Supplement: Lactobacillus strainVolunteers will take 1 capsule per day with the Lactobacillus strain for 6 months |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy women from 18 to 49 years old.
- Having suffered at least four outbreaks of vaginal yeast infection in the last year.
- Signed Informed Consent Form.
- Agree to provide the scheduled samples.
- Agree to perform gynecological examinations
Key exclusion criteria (4 listed)
- Being currently consuming or having consumed a probiotic in the two weeks prior to the study.
- Being under antibiotic treatment at the time of beginning the study.
- Being under pharmacological treatment for the treatment of candidiasis.
- Have an allergy to an antibiotic
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 |
|---|---|---|
| PlaceboEach participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits | Dietary supplement | Control group |
| Lactobacillus strainEach participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits | Dietary supplement | Probiotic group |
Primary outcome
Recurrence of candidiasis events
Time frame: 6 months
Total candidiasis events during intervention
Time between episodes
Time frame: 6 months
Days from baseline until candidiasis events
6 secondary outcomes
Determination of Candida in vaginal exudate by culture analysis
Time frame: 6 months
Microbiota of vaginal exudate
Time frame: 6 months
Gynecological examination
Time frame: 6 months
pH of vaginal discharge
Time frame: 6 months
Test of related clinical symptoms
Time frame: 6 months
Intensity of the related clinical symptoms
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jose Maldonado Lobón, PhD principal investigator
Biosearch S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus strain in people with Recurrent Vulvovaginal Candidiasis, run by Biosearch S.A. 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Jan 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Maldonado Lobón, PhD (+34 616556789, jamaldonado@biosearchlife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of candidiasis events (time frame: 6 months). The study lists 2 primary outcomes in all. 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 Jan 2021.