Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®
1 other identifier
interventional
134
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 4, 2009
CompletedFirst Posted
Study publicly available on registry
June 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedApril 20, 2021
April 1, 2021
7 months
June 4, 2009
April 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (1)
Probiotic
EXPERIMENTALDietary supplement
Interventions
2 gelules per day for 2 months then 1 gelule per day for 4 months
Eligibility Criteria
You may qualify if:
- women
- 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
You may not qualify if:
- 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;
- Contraindication to Gynopévaryl LP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pileje
Paris, 75015, France
Related Publications (1)
Cooke G, Watson C, Deckx L, Pirotta M, Smith J, van Driel ML. Treatment for recurrent vulvovaginal candidiasis (thrush). Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD009151. doi: 10.1002/14651858.CD009151.pub2.
PMID: 35005777DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
AZOULAY Catherine, MD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2009
First Posted
June 8, 2009
Study Start
June 1, 2009
Primary Completion
January 1, 2010
Study Completion
July 1, 2010
Last Updated
April 20, 2021
Record last verified: 2021-04