Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis
Primary Purpose
Recurrent Vulvovaginal Candidiasis
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Placebo
Lactobacillus strain
Sponsored by
About this trial
This is an interventional prevention trial for Recurrent Vulvovaginal Candidiasis focused on measuring Recurrent Vulvovaginal Candidiasis, Prevention, Probiotics
Eligibility Criteria
Inclusion Criteria:
- Healthy women from 18 to 49 years old.
- Having suffered at least four outbreaks of vaginal yeast infection in the last year.
- Signed Informed Consent Form.
- Agree to provide the scheduled samples.
- Agree to perform gynecological examinations
- Agree to report candidiasis events that occur during the study.
- Ability to complete surveys.
Exclusion Criteria:
- Being currently consuming or having consumed a probiotic in the two weeks prior to the study.
- Being under antibiotic treatment at the time of beginning the study.
- Being under pharmacological treatment for the treatment of candidiasis.
- Have an allergy to an antibiotic
Sites / Locations
- Hospital Universitario Infanta Elena
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Probiotic group
Arm Description
Volunteers will take 1 capsule per day with maltodextrin for 6 months
Volunteers will take 1 capsule per day with the Lactobacillus strain for 6 months
Outcomes
Primary Outcome Measures
Recurrence of candidiasis events
Total candidiasis events during intervention
Time between episodes
Days from baseline until candidiasis events
Secondary Outcome Measures
Determination of Candida in vaginal exudate by culture analysis
Analysis of the presence of Candida in vaginal exudate
Microbiota of vaginal exudate
Load of Candida, Lactobacillus, Gardnerella, Prevotella, Streptococcus and Bacteroides species in vaginal exudate samples
Gynecological examination
The gynecologist will perform a gynecological examination to check:Presence of erythema of the vulva, erythema of the vaginal mucosa, lumpy, whitish-coloured vulvar oedema and excoriation of the vulva
pH of vaginal discharge
Measurement of the pH of vaginal discharge
Test of related clinical symptoms
The volunteers will complete a test about presence of vaginal itching, vaginal burning, whitish vaginal discharge, dysuria and dyspareunia.
Intensity of the related clinical symptoms
Intensity (mild, moderate, intense) of the related clinical symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04639544
Brief Title
Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis
Official Title
Randomized, Triple-blind, Parallel-group Study to Evaluate the Effect of Consuming a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2021 (Anticipated)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosearch S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.
Detailed Description
Previous studies have demonstrated the effectiveness of certain probiotic strains in the treatment of vaginal candidiasis, alone or as an adjunct to antifungal treatments, as well as the effectiveness of a Lactobacillus strain as maintenance treatment after antifungal treatment to reduce the recurrence rate of candidiasis However, to date, no studies have evaluated the oral efficacy of a probiotic strain of Lactobacillus originally isolated from breast milk in the prevention of new vaginal yeast events in women with recurrent vaginal yeast infections.
The objective of this study is to evaluate the efficacy of the consumption of the one probiotic strain in the prevention of new vaginal candidiasis events in women with recurrent vaginal candidiasis. This is a preliminary study whose purpose is to know if this probiotic is effective in reducing the number of candidiasis events and / or increasing the time between possible relapses in women diagnosed with RVVC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Vulvovaginal Candidiasis
Keywords
Recurrent Vulvovaginal Candidiasis, Prevention, Probiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Volunteers will take 1 capsule per day with maltodextrin for 6 months
Arm Title
Probiotic group
Arm Type
Experimental
Arm Description
Volunteers will take 1 capsule per day with the Lactobacillus strain for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus strain
Intervention Description
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
Primary Outcome Measure Information:
Title
Recurrence of candidiasis events
Description
Total candidiasis events during intervention
Time Frame
6 months
Title
Time between episodes
Description
Days from baseline until candidiasis events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Determination of Candida in vaginal exudate by culture analysis
Description
Analysis of the presence of Candida in vaginal exudate
Time Frame
6 months
Title
Microbiota of vaginal exudate
Description
Load of Candida, Lactobacillus, Gardnerella, Prevotella, Streptococcus and Bacteroides species in vaginal exudate samples
Time Frame
6 months
Title
Gynecological examination
Description
The gynecologist will perform a gynecological examination to check:Presence of erythema of the vulva, erythema of the vaginal mucosa, lumpy, whitish-coloured vulvar oedema and excoriation of the vulva
Time Frame
6 months
Title
pH of vaginal discharge
Description
Measurement of the pH of vaginal discharge
Time Frame
6 months
Title
Test of related clinical symptoms
Description
The volunteers will complete a test about presence of vaginal itching, vaginal burning, whitish vaginal discharge, dysuria and dyspareunia.
Time Frame
6 months
Title
Intensity of the related clinical symptoms
Description
Intensity (mild, moderate, intense) of the related clinical symptoms
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy women from 18 to 49 years old.
Having suffered at least four outbreaks of vaginal yeast infection in the last year.
Signed Informed Consent Form.
Agree to provide the scheduled samples.
Agree to perform gynecological examinations
Agree to report candidiasis events that occur during the study.
Ability to complete surveys.
Exclusion Criteria:
Being currently consuming or having consumed a probiotic in the two weeks prior to the study.
Being under antibiotic treatment at the time of beginning the study.
Being under pharmacological treatment for the treatment of candidiasis.
Have an allergy to an antibiotic
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Maldonado Lobón, PhD
Phone
+34 616556789
Email
jamaldonado@biosearchlife.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Maldonado Lobón, PhD
Organizational Affiliation
Biosearch S.A.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Infanta Elena
City
Valdemoro
State/Province
Madrid
ZIP/Postal Code
28342
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Fernandez Romero, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis
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