About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Probiotic
- Placebo
Treatment groups
Sponsors and collaborators
The Archer-Daniels-Midland Company
Lead sponsor
Vedic Lifesciences Pvt. Ltd.
Collaborator