The purpose of the study is to assess the efficacy and safety of an oral probiotic product on the vaginal microbiome and on parameters of vaginal health. Eligible subjects will utilize the investigational product as directed for a period of 28 days. The vaginal microbial community and parameters of vaginal health will be measured at baseline and after 14 and 28 days of supplementation. A follow-up post-supplementation visit will be conducted on Day 42.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Once per day (QD), 28 days
Nutrasource
Guelph, Ontario, Canada
Changes in vaginal microbial community, via next generation sequencing.
Time frame: Day 28
Changes in vaginal microbial community, via next generation sequencing.
Time frame: Day 14 and 42
Changes in vaginal pH.
Time frame: Day 14, 28 and 42
Changes in Nugent Score (Scale of 0 to 10).
Time frame: Day 14, 28 and 42
Parameters of well-being, via Vulvovaginal Symptom Questionnaire.
Time frame: Day 14, 28 and 42
Safety as assessed by routine chemistry and hematology, and the monitoring of adverse events.
Time frame: Day 14, 28 and 42
Compliance as assessed by capsule counts of the returned IP.
Time frame: Day 14, 28 and 42
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