Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

This study has been terminated.
Sponsor:
Collaborator:
BioFortis
Information provided by (Responsible Party):
Pileje
ClinicalTrials.gov Identifier:
NCT00915629
First received: June 4, 2009
Last updated: October 5, 2011
Last verified: October 2011

June 4, 2009
October 5, 2011
June 2009
January 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00915629 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Vaginal Candidiasis
Dietary Supplement: Lactibiane candisis 5M
2 gelules per day for 2 months then 1 gelule per day for 4 months
Experimental: Probiotic
Dietary supplement
Intervention: Dietary Supplement: Lactibiane candisis 5M
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
134
July 2010
January 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00915629
2008-A01513-52
No
Pileje
Pileje
BioFortis
Principal Investigator: AZOULAY Catherine, MD
Pileje
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP