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Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

NCT00915629 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2021-04-20

No results posted yet for this study

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.

Conditions

  • Vaginal Candidiasis

Interventions

DIETARY_SUPPLEMENT

Lactibiane candisis 5M

2 gelules per day for 2 months then 1 gelule per day for 4 months

Sponsors & Collaborators

  • BioFortis

    collaborator OTHER

  • PiLeJe

    lead INDUSTRY

Principal Investigators

  • AZOULAY Catherine, MD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-01-31
Completion
2010-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915629 on ClinicalTrials.gov