Healthy VolunteerPhase 3NCT06837961
LC-Plasma on Immune Response and Reducing Symptoms of Upper Respiratory Infectious Diseases
A Phase 3 study testing LC-Plasma in people with Healthy Volunteer and Immune Response, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Immune Response
- What is being tested?
- LC-Plasma
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 241 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Apr 2025to 3 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Lactococcus Lactis JCM 5805 (LC-Plasma) Lactic Acid Bacteria on Immune Response and Reducing Symptoms of Upper Respiratory Infectious Disease in Australian Healthy Adults. Randomized Placebo-controlled Double-blind Parallel Group Study.
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.
- Conditions
- Healthy Volunteer, Immune Response
- Being tested
- LC-Plasma, Placebo
- Keywords
- LC-Plasma, Healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC-PlasmaDietary supplement
1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks
PlaceboOther
1 tablet containing 50mg MCC is taken daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| LC-Plasma | Experimental | 1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks Receives: Dietary Supplement: LC-Plasma |
| Placebo | Placebo comparator | 1 tablet containing 50mg microcrystalline cellulose is taken daily for 4 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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+
Measured: Week 0 to week 4
Secondary outcomes (4)
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+).
Measured: Week 0 to week 4
Anti-viral Activity of PBMCs
The anti-viral activity gene expression and IFN-α \& β production capability of PBMCs, both unstimulated and mildly stimulated with CpG, will be measured.
Measured: Week 0 to week 4
WURSS-24 Symptom Score
Symptoms will be measured using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24)
Measured: 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.
Measured: Week 0 to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start29 Apr 2025
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kirin Holdings Company, Limited
- Responsible party
- Sponsor
- Investigators
- Yusuke Ushida, Study director, Kirin Holdings Company, LimitedOsamu Kanauchi, Study director, Kirin Holdings Company, Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837961
- Sponsor's protocol ID
- GU/2025/073
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lactococcus Lactis JCM 5805 (LC-Plasma) Lactic Acid Bacteria on Immune Response and Reducing Symptoms of Upper Respiratory Infectious Disease in Australian Healthy Adults. Randomized Placebo-controlled Double-blind Parallel Group Study.
- ClinicalTrials.gov ID
- NCT06837961
- Acronym / sponsor ID
- GU/2025/073
- Conditions
- Healthy Volunteer, Immune Response
- Keywords
- LC-Plasma, Healthy volunteer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Kirin Holdings Company, Limited
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LC-Plasma | Experimental | Dietary Supplement: LC-Plasma1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks |
| Placebo | Placebo comparator | Other: Placebo1 tablet containing 50mg microcrystalline cellulose is taken daily for 4 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LC-Plasma1 tablet containing 50mg LC-Plasma is taken daily for 4 weeks | Dietary supplement | LC-Plasma |
| Placebo1 tablet containing 50mg MCC is taken daily for 4 weeks | Other | Placebo |
Primary outcome
The degree of activation of plasmacytoid dendritic cells (pDCs)
Time frame: 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+
4 secondary outcomes
Activation of Cytotoxic T Lymphocytes (CTLs)
Time frame: Week 0 to week 4
Anti-viral Activity of PBMCs
Time frame: Week 0 to week 4
WURSS-24 Symptom Score
Time frame: Week 0 to week 4
Rapid antigen test (RAT)
Time frame: Week 0 to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusuke Ushida study director
Kirin Holdings Company, Limited
Osamu Kanauchi study director
Kirin Holdings Company, Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LC-Plasma in people with Healthy Volunteer and Immune Response, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of activation of plasmacytoid dendritic cells (pDCs) (time frame: Week 0 to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.