Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis
Primary Purpose
Vulvo-vaginal Candidiasis
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Saccharomyces cerevisiae
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Vulvo-vaginal Candidiasis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Eurofins Optimed
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Saccharomyces cerevisiae CNCM I-3856
placebo
Arm Description
In this arm, subjects will be asked to consume one capsule of Saccharomyces cerevisiae CNCM I-3856 per day.
In this arm, subjects will be asked to consume one capsule of placebo per day.
Outcomes
Primary Outcome Measures
Enumeration of Candida albicans in a vaginal sampling
Secondary Outcome Measures
Full Information
NCT ID
NCT02345096
First Posted
January 19, 2015
Last Updated
December 2, 2016
Sponsor
Lesaffre International
Collaborators
Eurofins Optimed
1. Study Identification
Unique Protocol Identification Number
NCT02345096
Brief Title
Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lesaffre International
Collaborators
Eurofins Optimed
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvo-vaginal Candidiasis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saccharomyces cerevisiae CNCM I-3856
Arm Type
Active Comparator
Arm Description
In this arm, subjects will be asked to consume one capsule of Saccharomyces cerevisiae CNCM I-3856 per day.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
In this arm, subjects will be asked to consume one capsule of placebo per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Saccharomyces cerevisiae
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Enumeration of Candida albicans in a vaginal sampling
Time Frame
up to 2 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Cherbut, MD
Organizational Affiliation
Independant gynecologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurofins Optimed
City
Gières
ZIP/Postal Code
38610
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis
We'll reach out to this number within 24 hrs