NCT04639544

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Biosearch S.A. · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Recurrent Vulvovaginal Candidiasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-15
• Primary completion: 2021-08-31
• Completion: 2021-12-31
• First posted: 2020-11-20
• Last updated: 2021-01-22

Locations

1 site across 1 country: Spain