Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®
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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 |
- 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 ]
- 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 |
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 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 June 18, 2013