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| Name | Class |
|---|---|
| Kirin Holdings Company, Limited | INDUSTRY |
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The goal of this study is to evaluate the effects of LC-Plasma on the innate and acquired immune systems, including the activation of pDCs, which play a role in virus elimination, as well as to assess its efficacy in reducing clinical symptoms of upper respiratory infectious diseases in healthy adults. Researchers will compare LC-Plasma to placebo, participants will take a tablet containing LC-Plasma or placebo daily for 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LC-Plasma | Experimental | 1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks |
|
| Placebo | Placebo Comparator | 1 tablet containing 50mg microcrystalline cellulose is taken daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LC-Plasma | Dietary Supplement | 1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The degree of activation of plasmacytoid dendritic cells (pDCs) | The degree of activation of plasmacytoid dendritic cells (pDCs) is measured using the indicators CD304+/CD123+, CD86+, or HLA-DR+ | Week 0 to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Activation of Cytotoxic T Lymphocytes (CTLs) | The evaluation of CTLs responsible for virus elimination will be determined using the indicator (CD8+/CD3+/CD4-/IFN-γ+). | Week 0 to week 4 |
| Anti-viral Activity of PBMCs |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Occurrence of adverse events | Occurrence of adverse events | Week 0 to week 4 |
| Safety: Confirmation of medical history during study period | Confirmation of medical history during study period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yusuke Ushida | Kirin Holdings Company, Limited | Study Director |
| Osamu Kanauchi | Kirin Holdings Company, Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Griffith University | Southport | Queensland | 4215 | Australia |
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| Placebo |
| Other |
1 tablet containing 50mg MCC is taken daily for 4 weeks |
|
The anti-viral activity gene expression and IFN-α & β production capability of PBMCs, both unstimulated and mildly stimulated with CpG, will be measured.
| Week 0 to week 4 |
| WURSS-24 Symptom Score | Symptoms will be measured using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) | Week 0 to week 4 |
| Rapid antigen test (RAT) | Rapid antigen test (RAT) for Flu A/B, RSV & SARS-CoV-2. Will be conducted by participants once per week, with additional tests if symptoms are present. | Week 0 to week 4 |
| Week 0 to week 4 |