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

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

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.

Study Overview

• Status: Unknown
• Conditions: Recurrent Vulvovaginal Candidiasis
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Lactobacillus strain

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.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Maldonado Lobón, PhD; Phone Number: +34 616556789; Email: jamaldonado@biosearchlife.com

Study Locations

• Spain
  • Madrid
    • Valdemoro, Madrid, Spain, 28342
      • Hospital Universitario Infanta Elena
      • Contact: Cristina Fernandez Romero, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of candidiasis events	Total candidiasis events during intervention	6 months
Time between episodes	Days from baseline until candidiasis events	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of Candida in vaginal exudate by culture analysis	Analysis of the presence of Candida in vaginal exudate	6 months
Microbiota of vaginal exudate	Load of Candida, Lactobacillus, Gardnerella, Prevotella, Streptococcus and Bacteroides species in vaginal exudate samples	6 months
Gynecological examination	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	6 months
pH of vaginal discharge	Measurement of the pH of vaginal discharge	6 months
Test of related clinical symptoms	The volunteers will complete a test about presence of vaginal itching, vaginal burning, whitish vaginal discharge, dysuria and dyspareunia.	6 months
Intensity of the related clinical symptoms	Intensity (mild, moderate, intense) of the related clinical symptoms	6 months

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Investigators: Principal Investigator: Jose Maldonado Lobón, PhD, Biosearch S.A.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2021
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Probiotics; Prevention; Recurrent Vulvovaginal Candidiasis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections and Mycoses; Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Recurrence; Candidiasis, Vulvovaginal
• Other Study ID Numbers: P049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No