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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This is a virtual single-group clinical trial lasting 8 weeks to evaluate the effects of a probiotic vaginal suppository on vaginal health. Participants will use the Flora Power suppository daily for 5 consecutive days when experiencing common signs of vaginal imbalance. They will complete questionnaires and vaginal pH tests before and after product use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flora Power Probiotic Vaginal Suppository | Experimental | Participants will use the Flora Power suppository once daily at bedtime for 5 consecutive days when they feel they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flora Power Probiotic Vaginal Suppository | Dietary Supplement | The suppository contains Microcrystalline Cellulose, Ascorbic Acid, Vitamin C, Gelatin Capsule, Vaginal Probiotic Blend (Lactobacillus fermentum LF61, Lactobacillus acidophilus LA85, Lactobacillus plantarum Lp90), Magnesium Stearate, and Silicon Dioxide. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on Vaginal pH and Health | Measure the change in vaginal pH levels with a test strip from baseline to 24 hours after the 5-day intervention period. | Baseline, Day 6 (24 hours after the last suppository insertion) |
| Effect on Vaginal pH and Health | Measure the change in overall vaginal health from baseline to 24 hours after the 5-day intervention period with a questionnaire. | Baseline, Day 6 (24 hours after the last suppository insertion) |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Perception of Vaginal Freshness and Odor | Evaluate participants' perceptions of the vaginal suppository's impact on vaginal freshness and odor, as well as the support of a calm, soothed, and balanced vaginal environment. This outcome measure is assessed with questionnaires. | Baseline, Day 2, Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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