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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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This is a virtual single-arm trial that will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Gut health, bowel movements, stool looseness, constipation, bloating, and regularity will be evaluated at the Baseline and at each check-in. Likert scale responses will be statistically compared from Baseline to each check-in. Participant responses and product feedback will be presented as percentage scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test arm: ConcenTrace | Experimental | Participants will follow this weekly dosing schedule: Week 1: Day 1-3: take 5 drops of ConcenTrace with 8oz of water or flavored water. Day 4-7: take 5 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Week 2: Take 10 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Week 3: Take 15 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Week 4: Take 20 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Weeks 5 - 12: Take 40 drops of ConcenTrace 1x per day with 8 oz of water or flavored water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ConcenTrace | Other | The product contains concentrated seawater from Utah's inland sea. |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12] | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in stool consistency reported via the Bristol Stool Chart. [Timeframe: Baseline to Week 12] | The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. Type 1 has spent the longest time in the bowel and type 7 the least time. | 12 weeks |
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Inclusion Criteria:
Be generally healthy - must not live with any uncontrolled disease.
Exclusion Criteria:
Anyone taking any prescribed medication targeting the gut. Anyone taking any supplements targeting the gut within the past month. Anyone with any known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant. Anyone unwilling to follow the study protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Changes in bowel movement frequency. [Timeframe: Baseline to Week 12] |
The frequency that the participants have a bowel movement will be recorded via questionnaires. |
| 12 weeks |