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| Name | Class |
|---|---|
| Ganeden Biotech, Inc. | INDUSTRY |
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The purpose of this study is to investigate the effect of a GanedenBC30, a probiotic bacteria (Bacillus coagulans strain GBI-30, 6086), on the gut microbiome in healthy adults. Subjects will complete a 2-week run-in period prior to receiving GanedenBC30. The study is open-label and subjects will act as their own controls as the microbiome is unique to individuals. During the run-in period, subjects will collect two stool samples and complete daily bowel habit diaries in order to understand usual habits and profile the microbiome for each subject. 30 subjects will take part in this research study conducted at Nutrasource Diagnostics Inc. Subjects will take GanedenBC30 for four weeks. Stool samples will be collected at the end of the study and daily bowel habit diaries maintained for the duration of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GanedenBC30 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GanedenBC30 | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in the gut microbiome | Observe changes in the gut microbiome after 4 weeks of supplementation with GanedenBC30 as assessed by 16s RNA sequencing of feces | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in stool frequency | 4 weeks | |
| Change in stool consistency | Calculated using the Bristol stool scale form rating each bowel movement and averaging over each week | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by MedDRA coding | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Bier, MD | Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrasource Diagnostics Inc. | Guelph | Ontario | N1G 0B4 | Canada |
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| Changes severity of bloating as assessed by daily scores using a 4 point Likert scale | Determined using a 4 point Likert scale | 4 weeks |
| Changes severity of gas as assessed by daily scores using a 4 point Likert scale | 4 weeks |
| Changes severity of abdominal pain as assessed by daily scores using a 4 point Likert scale | 4 weeks |
| Changes in feeling of overall well-being as assessed by daily scores using a 5 point Likert scale | 4 weeks |