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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Recurrent Vulvovaginal Candidiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Probiotic group

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

Group Type EXPERIMENTAL

Lactobacillus strain

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Healthy women from 18 to 49 years old.
2. Having suffered at least four outbreaks of vaginal yeast infection in the last year.
3. Signed Informed Consent Form.
4. Agree to provide the scheduled samples.
5. Agree to perform gynecological examinations
6. Agree to report candidiasis events that occur during the study.
7. Ability to complete surveys.

Exclusion Criteria

1. Being currently consuming or having consumed a probiotic in the two weeks prior to the study.
2. Being under antibiotic treatment at the time of beginning the study.
3. Being under pharmacological treatment for the treatment of candidiasis.
4. Have an allergy to an antibiotic

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes