Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

Not Applicable

Terminated

• Conditions: Vaginal Candidiasis
• Interventions: Dietary Supplement: Lactibiane candisis 5M

• Registration Number: NCT00915629
• Lead Sponsor: PiLeJe

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-04
• Study First Submitted QC: 2009-06-04
• Study First Posted: 2009-06-08
• Primary Completion: 2010-01
• Study Completion: 2010-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Lactibiane candisis 5M	Dietary supplement

Primary Outcome Measures

Name	Time	Method
The primary objective of this study was to investigate if Lactibiane candisis 5M supplementation could lengthen the time to relapse after initial local cure	9 months

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this study is to compare the number of recurrence in the lactibiane candisis 5M group versus placebo.	2, 3, 6 and 9 months

Trial Locations

Locations (1)

Pileje; 🇫🇷 Paris, France