Effect of Saccharomyces Cerevisiae on Improving the Effec... | NCT02345096

Studies
Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis

NCT02345096

Sponsor

Lesaffre International

Status

Terminated

Last Update Posted

Dec 5, 2016Estimated

Enrollment

22Actual

Phase

Not Applicable

Conditions

Vulvo-vaginal Candidiasis

Interventions

Saccharomyces cerevisiae
Placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment difficulties

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jan 19, 2015

First Submission Date that Met QC Criteria

Jan 22, 2015

First Posted Date

Jan 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2016

Last Update Posted Date

Dec 5, 2016Estimated

Name	Class
Eurofins Optimed	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Dietary Supplement: Saccharomyces cerevisiae
placebo	Placebo Comparator	In this arm, subjects will be asked to consume one capsule of placebo per day.	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Saccharomyces cerevisiae	Dietary Supplement		Saccharomyces cerevisiae CNCM I-3856
Placebo

Measure	Description	Time Frame
Enumeration of Candida albicans in a vaginal sampling		up to 2 months

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided