Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

PiLeJe

Status

Terminated

Conditions

Vaginal Candidiasis

Treatments

Dietary Supplement: Lactibiane candisis 5M

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00915629

2008-A01513-52

Details and patient eligibility

About

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.

Enrollment

134 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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