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| Name | Class |
|---|---|
| Sabinsa Corporation | INDUSTRY |
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The purpose of this study is to determine whether Lactospore is safe in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactospore | Experimental | One tablet once daily, 30 minutes before a meal, preferably in the morning for 30 days |
|
| Placebo | Placebo Comparator | One tablet once daily, 30 minutes before a meal, preferably in the morning, for 30 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactospore | Dietary Supplement | Bacillus coagulans MTCC 5856 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability: Lab parameters | CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin levels | Over 30 days |
| Safety and Tolerability: Anthropometric safety measures | Blood pressure, Heart Rate, Weight, BMI | Over 30 days |
| Safety and Tolerability: Number of Adverse Events | Over 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale Wilson, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| Placebo |
| Other |
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