Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis
NCT Number: NCT06480604
Acronym: PROVELIA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Vulvovaginal Candidiasis
Interventions: DIETARY_SUPPLEMENT: Probiotic|DIETARY_SUPPLEMENT: Placebo
Sponsor: The Archer-Daniels-Midland Company
Collaborators: Vedic Lifesciences Pvt. Ltd.
Sex: FEMALE
Age: ADULT
Enrollment: 126
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07
Completion Date: 2025-05

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).

Primary Outcome Measures: Incidence of culture-confirmed VVC recurrence between baseline and day 180 as compared to placebo., Efficacy of a multi-strain probiotic on incidence of culture-confirmed VVC recurrence as compared to placebo, where VVC recurrence is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days., Day 0, Day 180
Secondary Outcome Measures: Occurrence of culture-confirmed VVC recurrence between baseline and day 90 as compared to placebo., Efficacy of a multi-strain probiotic on incidence of culture-confirmed VVC recurrence as compared to placebo, where VVC recurrence is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days., Day 0, Day 90|Time to first recurrence of VVC episode from baseline between probiotic and placebo groups., Time to first recurrence of VVC episode from baseline between probiotic and placebo groups, where VVC recurrence is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days., Day 0 to first VVC recurrence|Change in the number of days with VVC episode between probiotic and placebo groups., Efficacy of a multi-strain probiotic on the number of days with VVC episode as compared to placebo group, where VVC episode is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days., Duration (days) of VVC episodes, Day 0-180.|Change in severity of VVC episodes between probiotic and placebo groups., Efficacy of a multi-strain probiotic on the severity of VVC episodes as assessed by symptoms (itching/soreness, edema, dysuria, vaginal discharge, dyspareunia, erythema, fissures/excoriations) severity on a 4-point Likert Scale as compared to baseline and placebo.

The number of days of an episode will be captured using the e-dairy. First day of the episode will be considered as the day when the participant experiences onset of at least 2 moderate symptoms or at least one severe symptom on the 4-point Likert scale. The last day of the episode will be considered when there is no presence of VVC related clinical signs and symptoms and thus the composite score on the Likert scale is 0., During VVC episodes|Proportion of Candida albicans positive VVC episodes vs other pathogens between probiotic and placebo groups., Efficacy of a multi-strain probiotic on proportion of Candida albicans positive VVC episodes vs other pathogens., During VVC episodes|Number of administrations of vaginal pessaries during acute VVC episodes as compared to baseline and placebo., Number of vaginal pessaries applied during acute VVC episodes as compared to baseline and placebo. A Clotrimazole 100 mg pessary to be applied once daily at bedtime till no symptoms persist., During VVC episodes|Changes in vaginal health as assessed by vaginal pH and compared to baseline and placebo., Changes in vaginal health as assessed by vaginal pH, compared to baseline and placebo, using pH strips., Day 0, Day 90, Day 180|Changes in vaginal microbiology as assessed by vaginal Candida albicans culture and compared to baseline and placebo., Changes in vaginal microbiology as assessed by vaginal Candida albicans culture and compared to baseline and placebo., During episodes|Quality of life as assessed using SF-36 and compared to baseline and placebo., Changes in quality of life as assessed using SF-36 and compared to baseline and placebo.

Total and individual scoring of the 8 sections of the SF-36 questionnaire will be used to infer the improvement in quality of life improve. A high score defines a more favorable health state (maximum score 100)., Day 0, Day 90, Day 180
Other Outcome Measures: Influence of multi-strain probiotic on vaginal microbiome as compared to baseline and placebo., Effects of a multi-strain probiotic in vaginal microbiome as assessed by shotgun analysis and compared to baseline and placebo., Day 0, Day 90, Day 180