Effect of a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis

Sponsor

Biosearch S.A. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04639544

Collaborator

(none)

Enrollment

Location

Arms

10.5

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Vulvovaginal Candidiasis	Dietary Supplement: Placebo Dietary Supplement: Lactobacillus strain	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Randomized, Triple-blind, Parallel-group Study to Evaluate the Effect of Consuming a Lactobacillus Strain on the Prevention of Recurrent Vaginal Candidiasis

Anticipated Study Start Date :

Feb 15, 2021

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group Volunteers will take 1 capsule per day with maltodextrin for 6 months	Dietary Supplement: Placebo 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
Experimental: Probiotic group Volunteers will take 1 capsule per day with the Lactobacillus strain for 6 months	Dietary Supplement: Lactobacillus strain 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

Arm

Intervention/Treatment

Placebo Comparator: Control group

Volunteers will take 1 capsule per day with maltodextrin for 6 months

Dietary Supplement: Placebo

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

Experimental: Probiotic group

Volunteers will take 1 capsule per day with the Lactobacillus strain for 6 months

Dietary Supplement: Lactobacillus strain

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

Outcome Measures

Primary Outcome Measures

Recurrence of candidiasis events [6 months]
Total candidiasis events during intervention
Time between episodes [6 months]
Days from baseline until candidiasis events

Secondary Outcome Measures

Determination of Candida in vaginal exudate by culture analysis [6 months]
Analysis of the presence of Candida in vaginal exudate
Microbiota of vaginal exudate [6 months]
Load of Candida, Lactobacillus, Gardnerella, Prevotella, Streptococcus and Bacteroides species in vaginal exudate samples
Gynecological examination [6 months]
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 [6 months]
Measurement of the pH of vaginal discharge
Test of related clinical symptoms [6 months]
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 [6 months]
Intensity (mild, moderate, intense) of the related clinical symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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