Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

Vaginal Candidiasis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00915629
• Other study ID #: 2008-A01513-52
• Status: Terminated
• Phase: N/A
• Start date: June 2009
• Est. completion date: July 2010

Study information

• Verified date: April 2021
• Source: Larena SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 134
• Est. completion date: July 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Vaginal Candidiasis

Intervention

Dietary Supplement:
• Lactibiane candisis 5M
2 gelules per day for 2 months then 1 gelule per day for 4 months

Locations

Country	Name	City	State
France	Pileje	Paris

Sponsors (2)

Lead Sponsor	Collaborator
PiLeJe	BioFortis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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