Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis
NCT ID: NCT02345096
Last Updated: 2016-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
22 participants
INTERVENTIONAL
2015-01-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Saccharomyces cerevisiae CNCM I-3856
In this arm, subjects will be asked to consume one capsule of Saccharomyces cerevisiae CNCM I-3856 per day.
Saccharomyces cerevisiae
placebo
In this arm, subjects will be asked to consume one capsule of placebo per day.
Placebo
Interventions
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Saccharomyces cerevisiae
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
FEMALE
No
Sponsors
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Eurofins Optimed
INDUSTRY
Lesaffre International
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Cherbut, MD
Role: PRINCIPAL_INVESTIGATOR
Independant gynecologist
Locations
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Eurofins Optimed
Gières, , France
Countries
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Other Identifiers
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OP090414.LES
Identifier Type: -
Identifier Source: org_study_id
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