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Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

Primary Purpose

Vaginal Candidiasis

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Lactibiane candisis 5M

About this trial

This is an interventional prevention trial for Vaginal Candidiasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Pileje

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probiotic

Arm Description

Dietary supplement

Outcomes

Primary Outcome Measures

The primary objective of this study was to investigate if Lactibiane candisis 5M supplementation could lengthen the time to relapse after initial local cure

Secondary Outcome Measures

The secondary objective of this study is to compare the number of recurrence in the lactibiane candisis 5M group versus placebo.

Full Information

NCT ID

NCT00915629

First Posted

June 4, 2009

Last Updated

April 19, 2021

Sponsor

PiLeJe

Collaborators

BioFortis

1. Study Identification

Unique Protocol Identification Number

NCT00915629

Brief Title

Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Terminated

Study Start Date

June 2009 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PiLeJe

Collaborators

BioFortis

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginal Candidiasis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Probiotic

Arm Type

Experimental

Arm Description

Dietary supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactibiane candisis 5M

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AZOULAY Catherine, MD

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pileje

City

Paris

ZIP/Postal Code

75015

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

35005777

Citation

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.

Results Reference

derived

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Prevention of Recurrent Vulvovaginal Candidiasis With Lactibiane Candisis 5M®

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