Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

NCT ID: NCT00915629

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-07-31

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.

Conditions

Vaginal Candidiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Probiotic

Dietary supplement

Group Type: EXPERIMENTAL

Lactibiane candisis 5M

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Lactibiane candisis 5M

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

BioFortis

OTHER

Sponsor Role: collaborator

PiLeJe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AZOULAY Catherine, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Pileje

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35005777 (View on PubMed)

Other Identifiers

2008-A01513-52

Identifier Type: -

Identifier Source: org_study_id