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| Name | Class |
|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | NETWORK |
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The purpose of this study is to determine the optimal dose of IgY as assessed by changes in the inflammatory marker, C-reactive protein and investigate the effect of IgY on the gut microbiome as assessed by 16s RNA sequencing of fecal samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 9 maltodextrin capsules, once daily for 12 weeks |
|
| IgY Max Low-Dose (1g IgY Max) | Experimental | 2 Immunoglobulin Y capsules and 7 maltodextrin capsules, once daily for 12 weeks |
|
| IgY Max Mid-Dose (2g IgY Max) | Experimental | 4 Immunoglobulin Y capsules and 5 maltodextrin capsules, once daily for 12 weeks |
|
| IgY Max High-Dose (4.5g IgY Max) | Experimental | 9 Immunoglobulin Y capsules, once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoglobulin Y | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein | 2 weeks and 4 weeks | |
| Gastrointestinal Symptoms | Total Gastrointestinal Quality of Life Index (GIQLI) score | 2, 4, 8 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal microbiome | As measured by microbial abundance by 16S RNA sequencing of feces | 12 weeks |
| Stool frequency | Self-reported number of movements daily averaged over each week |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nutrasource | Guelph | Ontario | N1G 0B4 | Canada |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C016512 | IgY |
| C008315 | maltodextrin |
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| Placebo | Other |
|
|
| 12 weeks |
| Stool consistency | Bristol Stool Scale, self-reported per bowel movement and averaging over each week | 12 weeks |
| Adverse events | Number of subjects with a treatment emergent adverse effect | 12 weeks |