Clinical trial NCT04639544: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Vulvovaginal Candidiasis
Keywords: Recurrent Vulvovaginal Candidiasis
Prevention
Probiotics
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of candidiasis events
timeFrame: 6 months
measure: Time between episodes
timeFrame: 6 months
Secondary outcomes:
measure: Determination of Candida in vaginal exudate by culture analysis
timeFrame: 6 months
measure: Microbiota of vaginal exudate
timeFrame: 6 months
measure: Gynecological examination
timeFrame: 6 months
measure: pH of vaginal discharge
timeFrame: 6 months
measure: Test of related clinical symptoms
timeFrame: 6 months
measure: Intensity of the related clinical symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Valdemoro
country: Spain
facility: Hospital Universitario Infanta Elena
state: Madrid
Study officials:
affiliation: Biosearch S.A.
name: Jose Maldonado Lobón, PhD
role: PRINCIPAL_INVESTIGATOR
References: