Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

April 19, 2021 updated by: PiLeJe
Vulvovaginal candidiasis (VVC) is a common infection among women that is associated with considerable morbidity and health-care cost. 75% of women will suffer of Candida infection for at least one time in their life. 20% of women who suffer from VVC will have ≥ 4 episodes of VVC during the one year prior to the survey. 80% of these VVC are caused by Candida albicans. Current treatments, based on imidazoles, face many failures or recurrences. The type of probiotic Lactobacillus may participate in the prevention of recurrent vulvo-vaginitis in reducing the proliferation of intestinal Candida albicans, its adherence to the vaginal walls, the potentiation of its propagation. The primary objective of this study was to investigate if our supplementary treatment could improve the initial cure rate after vaginal econazole therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

134

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
      • Paris, France, 75015
        • PiLeJe

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women
  • 18-65 years
  • suffering from 4 or more episodes of VVC during the 1 year prior to the survey
  • all participants must be symptomatic with a microbiological proof of infection with candida albicans

Exclusion Criteria:

  • Pregnancy, lactation being
  • HIV infection, chemotherapy or illness serious enough to induce an immune deficiency. A diabetic patient will not be systematically excluded;
  • Vulvo-vaginitis and / or cervicitis specific, defined in a bacteriological examination by the presence of herpes virus, gonorrhea or chlamydia;
  • Bacterial Vaginosis or Trichomonas;
  • Use of vaginal probiotics in the months before inclusion;
  • Cure of probiotics in the months preceding the inclusion;
  • Contraindication to Gynopévaryl LP

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic
Dietary supplement
Dietary supplement: Lactibiane candisis 5M
2 gelules per day for 2 months then 1 gelule per day for 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study was to investigate if Lactibiane candisis 5M supplementation could lengthen the time to relapse after initial local cure
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary objective of this study is to compare the number of recurrence in the lactibiane candisis 5M group versus placebo.
Time Frame: 2, 3, 6 and 9 months
2, 3, 6 and 9 months

Collaborators and Investigators

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

Sponsor

PiLeJe

Collaborators

BioFortis

Investigators

  • Principal Investigator: AZOULAY Catherine, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 4, 2009

First Posted (Estimate)

June 8, 2009

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-A01513-52

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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