Vulvo-vaginal CandidiasisNCT02345096
Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis
A study testing Saccharomyces cerevisiae in people with Vulvo-vaginal Candidiasis, run by Lesaffre International at 1 site in France.
Trial summary
This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a randomized, double-blind, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvo-vaginal Candidiasis
- What is being tested?
- Saccharomyces cerevisiae
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Aug 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Premenopausal female patient with a clinical diagnosed vulvo-vaginal candidiasis
- Regularly menstruating women with normal gynaecological status
- Patient must use a contraception method
- Having given a written informed consent prior to selection
- Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
Who cannot join
- Pregnancy or breast feeding.
- Tumors in the genital tract or beast.
- Hypersensitivity to the study product.
- Uterine or vaginal bleeding of unknown origin.
- Use of systemic or intravaginal antibiotic or antifungal agents in the previous 14 days.
- Concomitant medication with antimycotics for other diagnoses.
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- Woman with known transmitted infections such as Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, herpes simplex, Trichomonas vaginalis, human papilloma virus, HIV 1 or 2.
- Immunocompromised individuals.
- Subjects not willing to stop taking probiotics in the form of dietary supplements or convenient goods
- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.
- Subject under administrative or legal supervision.
- Subject who participate to a previous study within 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis
This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a randomized, double-blind, placebo-controlled study.
- Conditions
- Vulvo-vaginal Candidiasis
- Being tested
- Saccharomyces cerevisiae, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces cerevisiaeDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Saccharomyces cerevisiae CNCM I-3856 | Active comparator | In this arm, subjects will be asked to consume one capsule of Saccharomyces cerevisiae CNCM I-3856 per day. Receives: Dietary Supplement: Saccharomyces cerevisiae |
| placebo | Placebo comparator | In this arm, subjects will be asked to consume one capsule of placebo per day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enumeration of Candida albicans in a vaginal sampling
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionAug 2016
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvo-vaginal 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesaffre International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed
- Responsible party
- Sponsor
- Investigators
- Robert Cherbut, MD, Principal investigator, Independant gynecologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345096
- Sponsor's protocol ID
- OP090414.LES
- Status last verified
- Dec 2016
- First submitted
- 19 Jan 2015
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis
- ClinicalTrials.gov ID
- NCT02345096
- Acronym / sponsor ID
- OP090414.LES
- Conditions
- Vulvo-vaginal Candidiasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Lesaffre InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Jan 2015 (estimated)
- 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.
This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a randomized, double-blind, placebo-controlled study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saccharomyces cerevisiae CNCM I-3856 | Active comparator | Dietary Supplement: Saccharomyces cerevisiaeIn this arm, subjects will be asked to consume one capsule of Saccharomyces cerevisiae CNCM I-3856 per day. |
| placebo | Placebo comparator | Dietary Supplement: PlaceboIn this arm, subjects will be asked to consume one capsule of placebo per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Premenopausal female patient with a clinical diagnosed vulvo-vaginal candidiasis
- Regularly menstruating women with normal gynaecological status
- Patient must use a contraception method
- Having given a written informed consent prior to selection
- Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
Key exclusion criteria (12 listed)
- Pregnancy or breast feeding.
- Tumors in the genital tract or beast.
- Hypersensitivity to the study product.
- Uterine or vaginal bleeding of unknown origin.
- Use of systemic or intravaginal antibiotic or antifungal agents in the previous 14 days.
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 |
|---|---|---|
| Saccharomyces cerevisiae | Dietary supplement | Saccharomyces cerevisiae CNCM I-3856 |
| Placebo | Dietary supplement | placebo |
Primary outcome
Enumeration of Candida albicans in a vaginal sampling
Time frame: up to 2 months
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
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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.
Robert Cherbut, MD principal investigator
Independant gynecologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saccharomyces cerevisiae in people with Vulvo-vaginal Candidiasis, run by Lesaffre International at 1 site in France.
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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 5 Dec 2016. 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 France. 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?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enumeration of Candida albicans in a vaginal sampling (time frame: up to 2 months). 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 5 Dec 2016.