NCT06480604

Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis

A Pilot Clinical Trial Assessing the Effect of a Multi-strain Probiotic on the Risk of Recurrence and Severity of Symptoms in Females With Recurrent Vulvovaginal Candidiasis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: The Archer-Daniels-Midland Company · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the effect of a multi-strain probiotic on the risk of recurrence and severity of symptoms in females with recurrent vulvovaginal candidiasis (R-VVC).

Detailed description

This study aims to investigate the efficacy of live bacteria on the incidence and severity of symptoms of vulvovaginal candidiasis (VVC) recurrence. The trial will be run in India and recruit women with recurrent vulvovaginal candidiasis (R-VVC).

Conditions

• Vulvovaginal Candidiasis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Participants in this arm will receive a daily dose of 2x10\^9 Colony Forming Units (CFU) of a multi strain probiotic (live bacterium), corresponding to 2 capsules once daily, for 6 months.
DIETARY_SUPPLEMENT	Placebo	Participants in this arm will receive an equivalent placebo for the duration of the study (6 months).

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2024-06-28
• Last updated: 2024-11-07

Locations

6 sites across 1 country: India