Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®
Information source: Pileje
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vaginal Candidiasis
Intervention: Lactibiane candisis 5M (Dietary Supplement)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Pileje Overall contact:
BIEUVELET Severine, PhD, Phone: 01.53.86.70.78, Email: s.bieuvelet@larena.fr
Summary
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.
Clinical Details
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: The primary objective of this study was to investigate if Lactibiane candisis 5M supplementation could lengthen the time to relapse after initial local cure
Secondary outcome: The secondary objective of this study is to compare the number of recurrence in the lactibiane candisis 5M group versus placebo.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
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
Locations and Contacts
BIEUVELET Severine, PhD, Phone: 01.53.86.70.78, Email: s.bieuvelet@larena.fr
Pileje, 37 Quai de Grenelle, Paris 75015, France
Additional Information
Starting date: June 2009
Last updated: June 4, 2009
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