Candidiasis, VulvovaginalNCT02859493
Effect of Saccharomyces Cerevisiae on Vulvo-vaginal Candidiasis
A study testing Saccharomyces cerevisiae in people with Candidiasis, Vulvovaginal, 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. The administration of yeast will be local (vaginal). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Candidiasis, Vulvovaginal
- What is being tested?
- Saccharomyces cerevisiae
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2016to Mar 2017
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subject suffering from a vulvo-vaginal candidiasis (according to clinical examination) characterized by a vaginal discharge associated with any of the following symptoms: itching and burning vaginal feeling, dyspareunia and dysuria.
- Amenorrheic subject, or subject having a regular menstrual cycle.
- Subject psychologically able to understand the study related information and to give a written informed consent.
- Subject having given freely and expressly her informed consent.
- Subject able to comply with protocol requirements, as defined in the protocol.
- Subject affiliated to a health social security system.
- Female subjects of childbearing potential should use a medically accepted contraceptive regimen (except latex condom, latex diaphragm, spermicidal) during the D0-D14 period, since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end, at the investigator's discretion
Who cannot join
- In terms of population
- Pregnant or nursing woman or planning a pregnancy during the study.
- Post-menopausal women.
- Subject who will have her period between the first and the second visit to the gynaecologist (between D0 and D7).
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- Subject in a social or sanitary establishment.
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- Subject suspected to be non-compliant according to the investigator's judgment.
- Subject enrolled in another clinical trial on the same test zone within the four previous weeks and during the study period, being in an exclusion period for a previous study, having tested a food supplement or a medication in the 4 previous weeks.
- Subject in an emergency situation. In terms of associated pathology
- Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk.
- Subject suffering from systemic diseases using concurrent therapy that may interfere with the evaluation of the study results.
- Subject with a known allergy to one of the component of the study products or to the medication (vaginal ovule and/or antifungal cream).
- Subject presenting an hypersensitivity to any antifungal of imidazole family or to one of the excipient.
- Uterine or vaginal bleeding of unknown origin
- Subject with known sexually transmitted infections such as Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, herpes simplex, Trichomonas vaginalis, human papilloma virus or HIV 1 or 2.
- Immunocompromised subjects
- Relating to previous or ongoing treatment
- Subject undergoing a topical treatment on the test area or a systemic or intravaginal treatment:
- antibiotics currently or within the past 2 weeks (systemic antibiotic are accepted if the treatment was stopped until the day before the inclusion visit)
- anti-fungal agents currently or within the past 2 weeks,
- anticoagulant within the past 2 weeks and during the study,
- anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study,
- corticosteroids during the 2 previous weeks and during the study,
- retinoids and/or immunosuppressors during the 3 previous months and during the study,
- any medication stabilized for less than one month.
- In terms of lifestyle
- Subject planning to change her usual hygiene habits and products during the study.
- Subjects not willing to stop taking probiotics dietary supplements and food products enriched with probiotics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Saccharomyces Cerevisiae on the Improvement of the Conventional Treatment for Vulvo-vaginal Infection to Candida Spp (Local Administration)
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. The administration of yeast will be local (vaginal).
- Conditions
- Candidiasis, Vulvovaginal
- Being tested
- Saccharomyces cerevisiae, Placebo
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces cerevisiaeDevice
PlaceboDevice
| Study group | Role | What they receive |
|---|---|---|
| Saccharomyces cerevisiae | Active comparator | Inactivated whole yeast Saccharomyces cerevisiae presented in vaginal capsules. 1 capsule a day for 14 days. Receives: Device: Saccharomyces cerevisiae |
| Maize starch and magnesium stearate | Placebo comparator | Placebo presented in a vaginal capsule. 1 capsule a day for 14 days Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diminution of the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis
valuation of the effect of vaginal administration of Saccharomyces cerevisiae on the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis, by counting Candida spp in vaginal samples, before treatment and after 7 days and 14 days of treatment, in addition to a conventional medical treatment and in comparison to the placebo product.
Measured: after 7 days and 14 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017
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 Candidiasis, VulvovaginalStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lesaffre International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859493
- Sponsor's protocol ID
- 15E2899
- Status last verified
- Jun 2018
- First submitted
- 4 Aug 2016
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Saccharomyces Cerevisiae on the Improvement of the Conventional Treatment for Vulvo-vaginal Infection to Candida Spp (Local Administration)
- ClinicalTrials.gov ID
- NCT02859493
- Acronym / sponsor ID
- 15E2899
- Conditions
- Candidiasis, Vulvovaginal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lesaffre InternationalIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- First posted
- 9 Aug 2016 (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. The administration of yeast will be local (vaginal).
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 | Active comparator | Device: Saccharomyces cerevisiaeInactivated whole yeast Saccharomyces cerevisiae presented in vaginal capsules. 1 capsule a day for 14 days. |
| Maize starch and magnesium stearate | Placebo comparator | Device: PlaceboPlacebo presented in a vaginal capsule. 1 capsule a day for 14 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject suffering from a vulvo-vaginal candidiasis (according to clinical examination) characterized by a vaginal discharge associated with any of the following symptoms: itching and burning vaginal feeling, dyspareunia and dysuria.
- Amenorrheic subject, or subject having a regular menstrual cycle.
- Subject psychologically able to understand the study related information and to give a written informed consent.
- Subject having given freely and expressly her informed consent.
- Subject able to comply with protocol requirements, as defined in the protocol.
Key exclusion criteria (28 listed)
- In terms of population
- Pregnant or nursing woman or planning a pregnancy during the study.
- Post-menopausal women.
- Subject who will have her period between the first and the second visit to the gynaecologist (between D0 and D7).
- Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
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 | Device | Saccharomyces cerevisiae |
| Placebo | Device | Maize starch and magnesium stearate |
Primary outcome
Diminution of the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis
Time frame: after 7 days and 14 days of treatment
valuation of the effect of vaginal administration of Saccharomyces cerevisiae on the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis, by counting Candida spp in vaginal samples, before treatment and after 7 days and 14 days of treatment, in addition to a conventional medical treatment and in comparison to the placebo product.
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 13 Jun 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Candidiasis, Vulvovaginal, 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 7 inclusion and 28 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 13 Jun 2018. 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?
Diminution of the vaginal load in Candida spp (Candida albicans, Candida glabrata) in subjects presenting a vulvo-vaginal candidosis (time frame: after 7 days and 14 days of treatment). 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 13 Jun 2018.