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| Name | Class |
|---|---|
| IGY Immune Technologies & Life Sciences Inc. | UNKNOWN |
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This study is to evaluate whether Muno-IgY is effective in enhancing immune health among adults over a six week period.
The goal of this single-arm interventional trial is to evaluate the safety and effectiveness of Muno-IGY in a sample population of 20 healthy adults over a six week period. The intervention will be compared to a baseline before ingestion of the supplement with both qualitative questionnaires, a daily diary, and microbiome data gathered by the SIMBA and LIMBA capsules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgY Supplement | Experimental | Participants will ingest the IgY supplement on a daily basis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgY supplement | Dietary Supplement | Ingesting the immune supplement over the experimental period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | To assess the safety of Muno-IgYâ„¢ in the small intestine. By monitoring the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Through study completion (Baseline to the end of the interventional period), an average of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary 1 | Investigate the association or determine if changes in the small and large intestine occur and fecal microbiomes through metagenomic analysis | Through study completion (Baseline to the end of the interventional period), an average of 6 weeks |
| Secondary 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gwen Duytschaever Duytschaever, PhD | Contact | 8664934633 | clinical@nimblesci.com | |
| Isaac Wong, MBT | Contact | 8664934633 | clinical@nimblesci.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nimble Science | Calgary | Alberta | T2L 1Y8 | Canada |
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To assess the bioavailability of the Muno-IgY, using the SIMBA capsule as a tool for sample collection |
| Through study completion (Baseline to the end of the interventional period), an average of 6 weeks |