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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 31, 2021

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.

Interventions

  • 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
  • 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

Arms, Groups and Cohorts

  • Placebo Comparator: Control group
    • Volunteers will take 1 capsule per day with maltodextrin for 6 months
  • Experimental: Probiotic group
    • Volunteers will take 1 capsule per day with the Lactobacillus strain for 6 months

Clinical Trial Outcome Measures

Primary Measures

  • Recurrence of candidiasis events
    • Time Frame: 6 months
    • Total candidiasis events during intervention
  • Time between episodes
    • Time Frame: 6 months
    • Days from baseline until candidiasis events

Secondary Measures

  • Presence of Candida in vaginal exudate
    • Time Frame: 6 months
    • Analysis of the presence of Candida in vaginal exudate
  • Microbiota of vaginal exudate
    • Time Frame: 6 months
    • Load of Candida, Lactobacillus, Gardnerella, Prevotella, Streptococcus and Bacteroides species in vaginal exudate samples
  • Gynecological parameters
    • Time Frame: 6 months
    • 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
    • Time Frame: 6 months
    • Measurement of the pH of vaginal discharge
  • Presence of related clinical symptoms
    • Time Frame: 6 months
    • Presence of vaginal itching, vaginal burning, whitish vaginal discharge, dysuria and dyspareunia.
  • Intensity of the related clinical symptoms
    • Time Frame: 6 months
    • Intensity (mild, moderate, intense) of the related clinical symptoms

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Biosearch S.A.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jose Maldonado Lobón, PhD, Principal Investigator, Biosearch S.A.
  • Overall Contact(s)
    • Jose Maldonado Lobón, PhD, +34 616556789, jamaldonado@biosearchlife.com

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