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
  Purpose

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.


Condition Intervention
Vaginal Candidiasis
Dietary Supplement: Lactibiane candisis 5M

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Pileje:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 134
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic
Dietary supplement
Dietary Supplement: Lactibiane candisis 5M
2 gelules per day for 2 months then 1 gelule per day for 4 months

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915629

Locations
France
Pileje
37 Quai de Grenelle, Paris, France, 75015
Sponsors and Collaborators
Pileje
BioFortis
Investigators
Principal Investigator: AZOULAY Catherine, MD
  More Information

No publications provided

Responsible Party: Pileje
ClinicalTrials.gov Identifier: NCT00915629     History of Changes
Other Study ID Numbers: 2008-A01513-52
Study First Received: June 4, 2009
Last Updated: October 5, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases

ClinicalTrials.gov processed this record on April 17, 2014