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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
126
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.
Participants in this arm will receive an equivalent placebo for the duration of the study (6 months).
Anand Multispeciality Hospital
Vadodara, Gujarat, India
RECRUITINGLife Care Hospital
Nashik, Maharashtra, India
RECRUITINGAMF's Moraya Multispeciality Hospital
Pune, Maharashtra, India
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.
Time frame: Day 0, Day 180
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.
Time frame: 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.
Time frame: 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.
Time frame: Duration (days) of VVC episodes, Day 0-180.
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ENT & Vertigo Clinic
Pune, Maharashtra, India
RECRUITINGVivaan Hospital
Sopāra, Maharashtra, India
RECRUITINGMatritva Women's Hospital
Vasai, Maharashtra, India
RECRUITINGChange 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Day 0, Day 90, Day 180