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).
Premenopausal women aged 18-50 years.
Women with a culture-confirmed active episode caused by Candida spp. (albicans or non-albicans) reported within 24-48 hours of evidence of clinical symptoms. (No medications should have been initiated before the sample for culture is collected).
Documented history of recurrence of at least 3 VVC episodes in the last 12 months confirmed by vaginal culture /clinical diagnosis.
Culture growth of Candida spp. causing VVC.
Post-menopausal and peri-menopausal women.
Pregnant/breast-feeding women.
Use of oral or vaginal anti-fungal medication in the last 14 days.
Vaginal culture suggestive of bacterial vaginosis (Nugent's score of 7-10), trichomonas vaginalis or Gardnerella vaginalis.
Parallel
Probiotic
Dietary supplementParticipants 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.
Placebo
Dietary supplementParticipants in this arm will receive an equivalent placebo for the duration of the study (6 months).
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.
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 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.
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.
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.
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.
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The Archer-Daniels-Midland Company
Lead sponsor
Vedic Lifesciences Pvt. Ltd.
Collaborator
