Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00915629

Enrollment

134

Registered

2009-06-08

Start date

2009-06-30

Completion date

2010-07-31

Last updated

2021-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Candidiasis

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.

Interventions

DIETARY_SUPPLEMENTLactibiane candisis 5M

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026