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

December 2, 2016 updated by: Lesaffre International

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Gières, France, 38610
        • Eurofins Optimed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Saccharomyces cerevisiae CNCM I-3856
In this arm, subjects will be asked to consume one capsule of Saccharomyces cerevisiae CNCM I-3856 per day.
Dietary supplement: Saccharomyces cerevisiae
Placebo Comparator: placebo
In this arm, subjects will be asked to consume one capsule of placebo per day.
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lesaffre International

Collaborators

Eurofins Optimed

Investigators

  • Principal Investigator: Robert Cherbut, MD, Independant gynecologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OP090414.LES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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