Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®
| Tracking Information | |||||
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| First Received Date ICMJE | June 4, 2009 | ||||
| Last Updated Date | October 5, 2011 | ||||
| Start Date ICMJE | June 2009 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00915629 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M® | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
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| Condition ICMJE | Vaginal Candidiasis | ||||
| Intervention ICMJE | Dietary Supplement: Lactibiane candisis 5M
2 gelules per day for 2 months then 1 gelule per day for 4 months |
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| Study Arm (s) | Experimental: Probiotic
Dietary supplement
Intervention: Dietary Supplement: Lactibiane candisis 5M |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 134 | ||||
| Completion Date | July 2010 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00915629 | ||||
| Other Study ID Numbers ICMJE | 2008-A01513-52 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pileje | ||||
| Study Sponsor ICMJE | Pileje | ||||
| Collaborators ICMJE | BioFortis | ||||
| Investigators ICMJE |
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| Information Provided By | Pileje | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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