A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health

Conditions
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Gut Health, Bowel Movements, Constipation, Bloating

Intervention / Treatment
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* Other: ConcenTrace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be male or female. Be aged over 18. Have a BMI less than 35. Have issues with digestion, heartburn, indigestion, gas, or constipation. Be willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study. Be generally healthy - must not live with any uncontrolled disease. Exclusion Criteria: Any person with a pre-existing chronic condition that might prevent the participant from adhering to the protocol, including any oncological and psychiatric disorders. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test arm: ConcenTrace<br>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. | Other: ConcenTrace<br>* The product contains concentrated seawater from Utah's inland sea.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |