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

Biosearch Life

Status: Unknown

Conditions: Recurrent Vulvovaginal Candidiasis

Treatments: Dietary Supplement: Lactobacillus strain; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04639544

P049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Probiotic group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus strain