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

Recurrent Vulvovaginal Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04639544
• Other study ID #: P049
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: Biosearch S.A.
• Contact: Jose Maldonado Lobón, PhD
• Phone: +34 616556789
• Email: jamaldonado[@]biosearchlife.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Recurrent Vulvovaginal Candidiasis

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Hospital Universitario Infanta Elena	Valdemoro	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of candidiasis events	Total candidiasis events during intervention	6 months
Primary	Time between episodes	Days from baseline until candidiasis events	6 months
Secondary	Determination of Candida in vaginal exudate by culture analysis	Analysis of the presence of Candida in vaginal exudate	6 months
Secondary	Microbiota of vaginal exudate	Load of Candida, Lactobacillus, Gardnerella, Prevotella, Streptococcus and Bacteroides species in vaginal exudate samples	6 months
Secondary	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
Secondary	pH of vaginal discharge	Measurement of the pH of vaginal discharge	6 months
Secondary	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
Secondary	Intensity of the related clinical symptoms	Intensity (mild, moderate, intense) of the related clinical symptoms	6 months