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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This is a virtual single-group study that will last 12 weeks. Participants will take 1 capsule every day, with water. Questionnaires will be completed at baseline, 2 weeks, 4 weeks, and 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Participants will take one capsule of the test product every day, with water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaginal Probiotic | Dietary Supplement | This product contains: Probiotic Blend - 5 Strains Lactobacillus acidophilus Lactobacillus rhamnosus Lactobacillus gasseri Lactobacillus acidophilus (NCFM) Lactobacillus casei |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in symptoms of bacterial vaginosis. | Participants will complete self-reported questionnaires reporting on incidence and severity of symptoms of bacterial vaginosis. | Baseline to Week 12 |
| Changes in vaginal odor. | Participants will complete self-reported questionnaires reporting their perceptions of their vaginal odor. Responses will be gathered on a 5-point Likert scale, with 0= the most favorable severe and 5= the least favorable response. | Baseline to Week 12 |
| Changes in vaginal itchiness. | Participants will complete self-reported questionnaires reporting the severity of vaginal itching. Responses will be gathered on a 5-point Likert scale, with 0= the least severe and 5= most severe response. | Baseline to Week 12 |
| Changes in vaginal discharge. | Participants will complete self-reported questionnaires reporting their perceptions of their vaginal discharge. Responses will be gathered on a 5-point Likert scale, with 0= the most favorable severe and 5= the least favorable response. | Baseline to Week 12 |
| Changes in vaginal dryness. | Participants will complete self-reported questionnaires reporting the severity of vaginal dryness. Responses will be gathered on a 5-point Likert scale, with 0= the least severe and 5= most severe response. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). | The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. | Baseline to Week 12 |
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Inclusion Criteria:
Women aged 18-40
Self-reported concerns with vaginal odor, itchiness, dryness, or discharge
Self-reported issues associated with bacterial Vaginosis, reporting three of the following symptoms:
Self-reported symptoms associated with irritable bowel syndrome (IBS), including three of the following symptoms:
Generally healthy - don't live with any uncontrolled chronic diseases
Willing to avoid the use of any intra-vaginal products (such as vaginal creams, gels, or medications) as well as suppositories during the study product use
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Changes in scores on the Bristol Stool Chart. | On the Bristol Stool Chart, stools are assigned a number from 1 to 7, from hardest to loosest. Normal stools are those in the middle of the chart, in the 3 to 4 range | Baseline to Week 12 |
| D004066 | Digestive System Diseases |