Healthy Volunteer, Immune Response
Conditions
Keywords
LC-Plasma, Healthy volunteer
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLC-Plasma
1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks
OTHERPlacebo
1 tablet containing 50mg MCC is taken daily for 4 weeks
Sponsors
Kirin Holdings Company, Limited
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Individuals who can provide a signed and dated informed consent form after confirming their willingness to participate. * Individuals willing to comply with all study procedures during the study period, including daily monitoring record compliance, cooperating with blood and urine sample collection and performing regular RATs. * Healthy people living in Australia aged 18-60 (both men and women). * Individuals who have received at least two doses of a SARS-CoV-2 vaccine, with at least two weeks having passed since the last dose. * Individuals who are not currently infected with SARS-CoV-2 and, if previously infected, have recovered and have been infection-free for at least four weeks. * Individuals who do not have any chronic or acute illnesses, including respiratory and/or gastrointestinal and/or other diseases, (e.g. hypertension, IBS, IBD, SLE, cancer, asthma, primary or secondary immunodeficiencies etc.), at the time of enrolment.
Exclusion criteria
* Individuals medically prescribed medications that would affect the immune and/or the inflammatory response. * Individuals deemed unsuitable for participation by Griffith CTU staff and/or the study clinician. * Active smokers/vapers and/or individuals with nicotine or drug habits. * Individuals currently participating in (or planning to participate in) other clinical trials. * Women who are pregnant, planning to become pregnant during the study period, or are currently breastfeeding. * Individuals unable to abstain from alcohol for two days prior to blood and urine sample collection. * Individuals unable to refrain from consuming other lactic acid bacteria supplements. * Individuals who are known to be HIV, HTLV-1, or HCV positive (based on answers to the enrolment questionnaire).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The degree of activation of plasmacytoid dendritic cells (pDCs) | Week 0 to week 4 | The degree of activation of plasmacytoid dendritic cells (pDCs) is measured using the indicators CD304+/CD123+, CD86+, or HLA-DR+ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activation of Cytotoxic T Lymphocytes (CTLs) | Week 0 to week 4 | The evaluation of CTLs responsible for virus elimination will be determined using the indicator (CD8+/CD3+/CD4-/IFN-γ+). |
| Anti-viral Activity of PBMCs | Week 0 to week 4 | The anti-viral activity gene expression and IFN-α & β production capability of PBMCs, both unstimulated and mildly stimulated with CpG, will be measured. |
| WURSS-24 Symptom Score | Week 0 to week 4 | Symptoms will be measured using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) |
| Rapid antigen test (RAT) | Week 0 to week 4 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety: Occurrence of adverse events | Week 0 to week 4 | Occurrence of adverse events |
| Safety: Confirmation of medical history during study period | Week 0 to week 4 | Confirmation of medical history during study period |
Countries
Australia
Outcome results
None listed