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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral probiotic product | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral probiotic product | Dietary Supplement | Once per day (QD), 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in vaginal microbial community, via next generation sequencing. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in vaginal microbial community, via next generation sequencing. | Day 14 and 42 | |
| Changes in vaginal pH. | Day 14, 28 and 42 | |
| Changes in Nugent Score (Scale of 0 to 10). |
| Measure | Description | Time Frame |
|---|---|---|
| Colonization of the vaginal microbiome. | Day 14, 28 and 42 | |
| Colonization of the GI microbiome. | Day 14, 28 and 42 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrasource | Guelph | Ontario | N1G 0B4 | Canada |
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| Day 14, 28 and 42 |
| Parameters of well-being, via Vulvovaginal Symptom Questionnaire. | Day 14, 28 and 42 |
| Safety as assessed by routine chemistry and hematology, and the monitoring of adverse events. | Day 14, 28 and 42 |
| Compliance as assessed by capsule counts of the returned IP. | Day 14, 28 and 42 |